GE HealthCare is correcting certain Carestation devices due to the risk that they may not provide effective ventilation when used in volume control ventilation mode, according to a medical device recall notice from the US Food and Drug Administration (FDA). 

In these systems, effective ventilation can be achieved in pressure control ventilation or pressure control ventilation volume guarantee modes—or with manual ventilation. 

If this issue occurs, GE HealthCare notes that it will be apparent to the Carestation user through observation and multiple alarms. The inflated bellows, visible through transparent glass, will stop moving, and an audible alarm and visual “Unable to Drive Bellows” message will alert the user. Additional alarms, including apnea, EtCO2 low, MVexp low, RR low, and TVexp low, will also alert the user to inadequate ventilation.

The use of the affected product may cause serious adverse health consequences, including failure of ventilation resulting in hypoxia and death.  

A spokesperson with GE HealthCare says the company is working with hospitals to address the issue and ensure continued device use. “Patient safety is our top priority. After identifying a potential issue with certain Carestation anesthesia delivery systems that may impact effective ventilation in one specific mode of ventilation, we are providing hospitals with instructions to follow to continue use of their devices,” the spokesperson says. “We will be correcting all impacted systems. There have been no reports of patient injury as a result of this potential issue.”

Intended use of the Carestation is to provide monitored anesthesia care, general inhalation anesthesia, and/or ventilatory support to a wide range of patients (neonatal, pediatric, and adult). The anesthesia systems are suitable for use in a patient environment, such as hospitals, surgical centers, or clinics by a clinician qualified in the administration of general anesthesia.

This recall involves correcting certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type.

The affected product names are Carestation 620/650/650c and 750/750c Anesthesia Systems. 

Customers in the US with questions about this recall should contact GE HealthCare Service at 1-800-437-1171.  

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By Rajani Kumar Sindavalam

Infusion pumps are essential instruments in contemporary healthcare, facilitating the precise delivery of fluids, medications, and occasionally nutrients. Ranging from simple syringe pumps to advanced smart pumps equipped with integrated drug libraries and connectivity options, these devices are crucial for patient care in various clinical environments.

Nevertheless, the growing complexity of infusion pumps, spurred by the need for improved functionality and seamless integration within the healthcare system, presents considerable challenges. Risks to patient safety arise from medication errors, usability concerns, cybersecurity threats, and interoperability issues, which impede the complete achievement of their clinical capabilities.

Systems engineering—an interdisciplinary domain dedicated to the design, development, and management of intricate systems throughout their lifecycles—provides a systematic framework to tackle these challenges. By embracing a comprehensive viewpoint that considers all stakeholders, system elements, and their interrelations, the medical technology sector can facilitate the creation of safer, more user-centric, and genuinely intelligent infusion pumps.

Challenges in Infusion Pump Development

Developing infusion pumps is complex and necessitates a robust systems engineering methodology. These challenges include both technical and clinical dimensions, each with direct implications for patient safety and regulatory compliance:

• Safety-Critical Nature: Infusion pumps directly impact patient health. A malfunction—such as the over- or under-administration of essential medications—can have serious or life-threatening consequences. Safety must remain the top priority throughout every stage of development.
• Stringent Regulatory Requirements: Medical devices, including infusion pumps, are subject to rigorous oversight from regulatory bodies such as the US Food and Drug Administration and European Medicines Agency. Compliance demands extensive documentation, testing, and validation—core elements of systems engineering that ensure quality and accountability.
• Human Factors and Usability: These devices are often used in fast-paced clinical environments. Poorly designed interfaces, unclear alarms, or complex workflows increase the likelihood of error. Integrating human factors engineering into the design process helps ensure devices are intuitive and safe to use.
• Software Complexity: Modern pumps rely heavily on embedded software for drug delivery, alarms, and connectivity. As functionality expands, so does the potential for defects. Addressing this complexity requires disciplined software development practices.
• Interoperability and Data Integration: Infusion pumps must integrate with systems like EHRs and pharmacy platforms. Achieving seamless, secure interoperability requires careful design and validation to maintain data integrity.
• Cybersecurity Threats: Network-connected pumps are vulnerable to cyber threats that could impact functionality or expose patient data. Embedding robust security protocols from the start is essential.
• Lifecycle Management: Systems engineering must span the entire product lifecycle, including manufacturing, maintenance, and disposal. Ongoing oversight ensures continued performance and safety.

Putting Systems Engineering to Work

A systematic application of systems engineering principles helps navigate these challenges. The process begins with stakeholder analysis and requirements elicitation—identifying the needs of patients, clinicians, pharmacists, engineers, and regulators. For example, insights from ICU nurses can inform interface design and alarm functionality.

Functional analysis and system architecture design follow, breaking the pump into components such as fluid delivery, occlusion detection, user interface, and data transmission. A well-structured architecture promotes modularity, testability, and long-term maintainability.

Risk management is central. Structured tools like Failure Modes and Effects Analysis and hazard analysis help identify and mitigate risks early. For instance, analyzing potential failure points in the pump mechanism can support the development of more responsive occlusion detection.

Human factors engineering and usability testing ensure that the pump is intuitive and minimizes user error. Simulated clinical testing with representative users helps refine visual and auditory alarms and workflow steps.

Given the pump’s software dependence, software systems engineering is vital. This includes managing requirements, developing architecture, performing rigorous testing, and ensuring cybersecurity. Following standards like IEC 62304 and using secure coding practices reduces risk.

Verification and validation—from unit tests to system-level evaluations and clinical trials—confirm the device meets specifications and performs safely.

Configuration management and traceability maintain oversight of documentation, components, and changes across the lifecycle. Traceability matrices linking requirements to test cases and risk controls reinforce a disciplined development process.

Finally, post-market surveillance ensures continued device safety. Monitoring field performance, collecting feedback, and managing recalls allow for continuous improvement based on real-world data.

Powering the Next Generation of Smart Infusion Pumps

Emerging technologies such as artificial intelligence (AI), machine learning (ML), and improved connectivity are propelling the development of smart infusion pumps. Systems engineering ensures these innovations are integrated safely and effectively.

Predictive analytics powered by AI/ML can identify potential issues like occlusions or low medication levels before they occur. Systems engineering defines the requirements for these algorithms, supporting accuracy and safety.

Connectivity and interoperability are essential. Pumps must reliably exchange data with EHRs, pharmacy systems, and other devices. Engineering principles guide the development of secure interfaces and resilient communication protocols.

Looking ahead, real-time patient data may be used to adjust infusion rates dynamically. Developing these adaptive control features requires validated algorithms and integration into reliable feedback systems.

What’s Next—and What’s Needed

To support the continued evolution of infusion pumps, manufacturers should embrace key best practices. These include early and ongoing stakeholder engagement to ensure development is aligned with real-world clinical needs. Involving users from the outset helps avoid costly redesigns later.

Additionally, comprehensive risk management should be embedded across all phases of development as proactively addressing safety risks leads to safer, more robust devices.

Human-centered design, including attention to usability and clinical workflows, helps ensure safe and intuitive operation in demanding settings, while interoperability remains essential. Standardized communication protocols simplify integration with other health IT systems.

Software and cybersecurity practices must evolve with the technology. Adhering to development standards and adopting secure design principles will reduce vulnerabilities.

Additionally, post-market surveillance using real-world data helps identify issues and guide iterative improvements, and ethical considerations around AI and ML should be addressed early. Transparency, accountability, and bias mitigation are critical for responsible integration.

Finally, industry-wide collaboration can accelerate progress. Sharing best practices, tools, and lessons learned contributes to safer, smarter infusion technology.

The Path Forward

Advancing smart infusion pumps requires a comprehensive approach grounded in systems thinking. By applying engineering principles across the entire lifecycle—from early design to post-market surveillance—developers can build safer, more reliable devices.

As the medtech industry continues to innovate, systems engineering provides the foundation for addressing complexity and unlocking the full potential of infusion pump technology to improve patient outcomes. 

About the Author: Rajani Kumar Sindavalam is a senior technical manager and medical device leader at HCLTech. He has more than 19 years of experience supporting the development of medical technologies, including infusion pumps, bedside monitors, dialysis cyclers, and nerve stimulators.

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Creo Medical has received clearance from the US Food and Drug Administration (FDA) for its SpydrBlade Flex device, completing the company’s regulatory approvals for its suite of advanced energy gastrointestinal (GI) tools.

SpydrBlade Flex is a multi-modal endoscopic device that provides both cutting and coagulation functions—features traditionally found in laparoscopic surgery—via a flexible endoscope. It is designed for a range of therapeutic endoscopy procedures and combines multiple functionalities in a single tool.

Following its commercial launch in Europe in March 2025, SpydrBlade Flex has been used in procedures including:

• Zenker’s Peroral Endoscopic Myotomy 
• Colonic ESD
• Oesophageal ESD
• POEM
• F-POEM

With FDA clearance secured, Creo plans to begin commercial rollout in the United States through its direct sales force and clinical partnerships.

The clearance comes shortly after the American Medical Association’s May 2025 decision to introduce reimbursement codes for endoscopic submucosal dissection, establishing a reimbursement pathway that may support broader adoption of tools like SpydrBlade Flex.

The device is part of Creo’s lineup of advanced energy GI products, which also includes Speedboat UltraSlim, Speedboat Notch, and MicroBlate Fine.

“FDA clearance for SpydrBladeTM Flex confirms the strength and novelty of our GI product portfolio. The device has overcome significant design challenges, with unique intellectual property that sets it apart in the market,” says Craig Gulliford, chief executive officer of Creo Medical, in a press release.

Photo caption: SpyderBlade Flex

Photo credit: Creo Medical

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Agiliti announced the launch of its new NP Line of stretcher support surfaces that are clinically engineered for safer patient care.

Compatible with the majority of acute care stretchers, the three non-powered support surfaces feature a breathable, four-way stretch top cover fabric and radio frequency-welded seams for enhanced durability and less risk of microbial infiltration.

“Stretcher pads are among the most used pieces of medical equipment in emergency and perioperative departments and subject to rapid wear and tear,” says Tim McCarty, general manager of beds and therapeutic support surfaces at Agiliti, in a release. “We designed the NP Line of stretcher support surfaces with features to help improve patient comfort, reduce the risk of contamination, and offer customers a highly durable surface option in their highest-volume environments.”

The NP Line includes the following products:

• NP Adjust ST, which features self-adjusting foam-filled air cells that respond to patient weight and movement. This aims to promote immersion, pressure redistribution, and comfort.
• NP Trio ST, which features three layers of foam and a sloped heel zone to support varying pressure redistribution needs.
• NP Duo ST, which features two layers of foam to provide consistent support from head to heel. The top layer of Visco foam is softer, while the firmer bottom layer adds stability and prevents bottoming out.

The NP Adjust ST and NP Trio ST also feature a CoreShield layer to protect internal components from contamination and a layer of CuPro copper- and gel-infused foam to help enhance microclimate by dissipating heat and moisture.

Research published by Agiliti shows that compromised surfaces pose nearly six times more risk for cross-contamination to patients. The NP Line is the latest addition to the company’s portfolio of support surface technologies designed for more advanced care across multiple clinical settings. 

Photo caption: NP Adjust ST

Photo credit: Agiliti

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Johnson & Johnson MedTech has announced the US launch of its Soundstar Crystal ultrasound catheter, designed to provide enhanced intracardiac echocardiography (ICE) imaging during cardiac ablation procedures.

The 2D ICE catheter offers improved image quality compared to previous ICE devices and integrates with the company’s Carto 3 Mapping System, including the CartoSound Fam module. Powered by an artificial intelligence algorithm, CartoSound Fam enables automated generation of left atrial anatomy using images captured from ultrasound catheter rotation in the right atrium. This integration is intended to streamline the mapping workflow for electrophysiologists treating cardiac arrhythmias.

“During the cases I performed with the Soundstar Crystal ultrasound catheter, I was impressed by the clear visualization, tissue definition, enhanced far-field imaging, and full integration with other platforms,” says Amin Al-Ahmad, MD, St. David’s HealthCare, Austin, TX.

ICE is widely used during catheter ablation procedures to visualize cardiac structures in real time, monitor catheter-tissue contact, and identify potential complications. When paired with 3D electroanatomical mapping systems like Carto 3, ICE imaging can support zero-fluoroscopy procedures and allow for ablations under conscious sedation without the need for esophageal intubation.

The Soundstar Crystal catheter joins Johnson & Johnson MedTech’s broader ultrasound portfolio, which also includes the NuVision catheter for 4D cardiac imaging.

According to the company, the growing prevalence of atrial fibrillation—which affects more than 50 million people globally and over 8 million in the US—continues to drive demand for ablation tools. Left untreated, AFib can progress and lead to complications such as heart disease or stroke.

Photo caption: Soundstar Crystal ultrasound catheter

Photo credit: Johnson & Johnson MedTech

Cardinal Health has launched its multi-parameter, single-patient use vital signs monitoring cable and lead wire system, the Kendall DL Multi System, in the United States. The system enables continuous monitoring of cardiac activity, blood oxygen level, and temperature through one point of connection.

Designed to travel with the patient from admission to discharge, the system is intended to support patient transport, improve clinician workflows, and provide consistent monitoring to help guide care decisions.

“The addition to the Kendall DL portfolio removes complexity for care teams and supports clinical performance with multi-parameter monitoring,” says Rachel Schott, global vice president for specialty products at Cardinal Health, in a release. “The product streamlines steps clinicians must follow and controls lead wire clutter with its built-in cable management system.”

The Kendall DL Multi System includes clinically proven technology designed to reduce the incidence of false “leads off” alarms—indications that wires are not properly connected to the patient—as well as motion-related artifacts in electrocardiogram tracings. According to Cardinal Health, this can result in cleaner tracings and assist clinicians in prioritizing care.

As a single-patient use product, the system may help reduce cross-contamination risks associated with reusable lead wires. Cardinal Health notes this can lower the risk of infection and the potential for extended hospital stays or readmissions. The system is eligible for medical device reprocessing through the company.

“By enabling more efficient workflows and supporting clinical performance, this solution can potentially benefit the financial performance of healthcare providers,” Schott says in a release. “Expanding our Kendall DL offerings reflects our commitment to addressing clinical and operational challenges across healthcare settings.”

The Kendall DL Multi System is now available to health systems in the US.

Photo caption: Kendall DL Multi System

Photo credit: Cardinal Health

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Restore Robotics announced that Eugene Dickens, MD, FACS, at Hillcrest Medical Center in Tulsa, Okla, conducted the first-in-human use of a remanufactured da Vinci  Xi robotic instrument on a patient using the newest model robotic surgical system, the da Vinci 5. In addition, Panama City Surgery Center performed the first-in-human use on a da Vinci Xi, which is the workhorse of the da Vinci robotics surgical systems.

Restore Robotics holds the only clearance from the US Food and Drug Administration (FDA)  to remanufacture Xi robotic instruments, which are made available to hospitals through Encore Medical Device Repair, Restore Robotics’ commercial partner. With the clearance to remanufacture da Vinci Xi robotic monopolar scissors, Restore Robotics and Encore are offering hospitals and surgery centers a new option for sourcing robotic instruments beyond the original manufacturer.

“Our FDA clearance means that the remanufactured instrument is substantially equivalent to a new instrument,” says Clif Parker, CEO of Restore Robotics, in a release. “But the real-life use of the remanufactured instrument on a patient is the ultimate proof that our remanufactured instruments are safe and effective.”

Restore Robotics and Encore are launching their robotic remanufacturing program in large hospital systems across the country.

“I just had the chance to use the remanufactured Restore Robotics scissor. I have to say it worked perfectly. You couldn’t tell anything was different from a factory-fresh instrument. Knowing the instrument has been through 100% quality checks and calibration gave me the peace of mind to use it with confidence,” says Dickens in a release. “It is a great feeling to know I can deliver uncompromised quality to my patient at a reduced cost to the healthcare system. The environmental impact of using sustainable goods probably has the biggest impact globally and should not go without mention.”

Mike Madewell, CEO of Panama City Surgery Center, says in a release, “We have been purchasing certified pre-owned instruments from Restore for our da Vinci Xi robot, and when we used the remanufactured monopolar scissors, it performed just like a new instrument out of the box. There was no discernible difference between the Restore instrument and a new one.”

Restore Robotics is working on getting clearances for other da Vinci robotic instruments.

Photo caption: da Vinci XI instruments

Photo credit: Intuitive Surgical

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The US Food and Drug Administration (FDA) has granted 510(k) clearance for Iradimed Corporation’s MRidium 3870 infusion pump system, the company’s next-generation magnetic resonance imaging (MRI)-compatible intravenous infusion pump.

Designed for use in MRI environments, the MRidium 3870 builds on Iradimed’s earlier systems, which the company says remain the only non-magnetic infusion pumps cleared for use during MRI procedures.

“We are thrilled to receive FDA 510(k) clearance for the MRidium 3870, a milestone that underscores our commitment to advancing MRI-compatible medical technology,” says Roger Susi, president and CEO of Iradimed Corporation, in a release. “This long-awaited clearance reflects our productive collaboration with the FDA to meet evolving and stringent regulatory requirements. The MRidium 3870 empowers clinicians to deliver critical IV fluids and medications safely and predictably in MRI environments, improving patient outcomes and operational efficiency.”

Iradimed expects to begin rolling out the MRidium 3870 at select healthcare facilities in the fourth quarter of 2025, with broader commercial distribution to follow in 2026.

The company, which received FDA clearance for its first-generation infusion pump in 2005, also manufactures non-magnetic patient monitoring systems designed for use in MRI suites. According to Iradimed, the new device expands its offerings for hospitals seeking MRI-compatible solutions in anesthesiology and critical care.

Photo caption: MRidium 3870 infusion pump system

Photo credit: Iradimed Corporation

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AirStrip, a provider of vendor-agnostic clinical surveillance and decision support technologies, announced the launch of AirStrip Alarm Management, an integrated platform that modernizes how hospitals manage clinical alarms. 

This US Food and Drug Administration-approved solution routes critical alerts to clinicians’ mobile devices, supported by waveform vital sign data, aiming to help care teams respond faster and reduce alarm fatigue across care settings.

Built to integrate with existing systems, AirStrip Alarm Management supports a vendor-neutral approach to alarm workflows. The MDI library enables hospitals to access data from disparate devices and systems, enhancing visibility and decision-making.

“This FDA-approved platform is a meaningful advancement for healthcare systems. It simplifies alarm management, eases clinician workload, and contributes to a safer, more sustainable care environment especially for high-risk, high-cost patient care,” says Dr Patrick Soon-Shiong, chairman of AirStrip’s board of directors, in a release. 

With support from AirStrip, hospitals can custom-select configurations for alert escalations and notifications. This platform integrates with staff assignment solutions to avoid over-alerting while supporting unit-specific overrides, delivering clinically actionable alerts. The centralized dashboard allows end users to dispatch alerts, document significant arrhythmias to the EHR, and track alarms in near-real time, offering automated audit trails for workflow transparency.

Clinicians receive alerts enriched with contextual information and waveforms, allowing them to act immediately or escalate when necessary. The Alert Tracker feature gives hospital leaders insight into alarm activity across the system with near real-time updates and detailed logs.
“As someone who experiences alarm fatigue firsthand, I see the immediate clinical value of this solution. It brings clarity to urgent situations and helps us deliver faster, safer care,” says Haris Naseem, MD, AirStrip’s CEO and a practicing cardiac electrophysiologist, in a release.

Photo caption: AirStrip

File photo/Provided

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Olympus announced it has received US Food and Drug Administration 510(k) clearance for its EZ1500 series endoscopes featuring Extended Depth of Field (EDOF) technology.

EDOF endoscopes—the GIF-EZ1500 gastroscope and the CF-EZ1500DL/I colonoscope—represent Olympus’ latest innovation as part of the EVIS X1 endoscopy system. By allowing physicians to obtain sharp images, EDOF technology allows an entire lesion to be kept in focus and may aid in detection as endoscopists inspect the mucosal lining of the GI tract.

According to Olympus, EDOF technology creates an image in total focus by using two prisms to split light entering the endoscope lens into two separate beams with near- and far-focused images. Those beams are then projected simultaneously onto an image sensor, combining them into one image with a wide depth of field.

Compared to the previous generation of Olympus scopes, Olympus says this technology provides improved visibility and less blurring. The EZ1500 series EDOF scopes allow for closer distance in normal mode compared to the CF-HQ190L/I—3mm versus 5mm—without blurring, limiting the need to switch from normal to near mode.

Imaging Modes and Ergonomic Design

The GIF-EZ1500 gastroscope and the CF-EZ1500DL/I colonoscope also feature a lightweight ErgoGrip control section and compatibility with Texture and Color Enhancement Imaging (TXI), Red Dichromatic Imaging (RDI), and Narrow Band Imaging (NBI) technologies when connected to the EVIS X1 CV-1500 video system center.

The ErgoGrip control section of EVIS X1 endoscopes is 10% lighter than the 190 series scope control section and features a rounded handle and easy-to-reach angulation control knobs and switches to accommodate users with small hands and support scope maneuverability.

“Our goal is to elevate the standard of endoscopy, and Extended Depth of Field technology represents Olympus’ most advanced scope technology to help physicians drive the best clinical outcomes for advancing gastrointestinal procedures,” says Kurt Heine, senior vice president and general manager for gastrointestinal solutions at Olympus, in a release.

TXI, RDI, BAI-MAC and NBI technologies are not intended to replace histopathological sampling as a means of diagnosis. These are adjunctive tools for endoscopic examination that can be used to supplement Olympus white light imaging.

Photo caption: Olympus announces FDA 510(k) clearance of its EZ1500 series endoscopes featuring Extended Depth of Field (EDOF) technology as part of the EVIS X1 endoscopy system

Photo credit: Olympus