Tag: FDA recall

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Fresenius Kabi Issues Critical Software Update for Ivenix Infusion Pumps

FDA identifies Class I recall as most serious type due to software anomalies that may cause unexpected shutdowns and interface freezing.

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BD Advises Biomed Inspection of Dropped Alaris Pump Modules

The company advises taking any dropped or severely jarred modules out of service and sending them to biomedical engineering for inspection before reuse.

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FDA Expands Early Alert Program for High-Risk Device Issues

The initiative provides faster notifications on potentially high-risk removals or corrections for all medical devices.

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Fresenius Kabi Issues Critical Software Update for Ivenix Infusion Pumps

FDA identifies Class I recall as most serious type due to software anomalies that may cause unexpected shutdowns and interface freezing.

FDA Flags Defibrillator Lead Issue Linked to Serious Injuries, Deaths

Aug 6, 2025

Boston Scientific’s Endotak Reliance leads with ePTFE-coated coils may reduce shock efficacy due to coil calcification.

Philips Respironics Updates Use Instructions for Certain BiPAP Devices

Aug 5, 2025

Updated guidance addresses ventilator inoperative alarm failures that may lead to therapy loss, with 13 injuries and eight deaths reported.

Baxter’s Life2000 Cyber Recall Draws Attention to FDA’s Focus on Software Safety Risks

Jul 23, 2025

A cybersecurity vulnerability that prompted Baxter to recall certain Life2000 ventilators is being seen by some industry experts as part of a broader shift in how the FDA treats software-related risks.

FDA Issues Early Alert on Infusion Pump Issue from Baxter

Jul 22, 2025

The FDA issued an early alert under its recall communications pilot citing 79 injuries and two deaths linked to Baxter’s Novum IQ infusion pump.

GE HealthCare Recalls Certain Carestation Devices Over Ventilation Risk

Jun 23, 2025

The Carestation anesthesia systems are being recalled due to a risk of ineffective ventilation in volume control mode, which could lead to serious injury or death.

Zyno Medical Recalls Infusion Pumps Over Software Issue

Jun 18, 2025

Certain Z-800 series infusion pumps may malfunction due to unverified software, prompting a Class I recall by the FDA.

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Medtronic Removes Tracheostomy Tube Over Risk of Flange Disconnection

Medtronic advises customers to return affected adult flexible tubes due to potential airway blockage and respiratory emergencies.