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.
Category: Recalls
Recalls
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Recalls
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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.
Recalls
Latest
FDA Alerts Users to Purge Pressure Issues in Automated Impella Controller
The alert links purge retainer failures to potential pump stops and loss of hemodynamic support; the manufacturer is planning a service update.
Recalls
Latest
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 Announces Class I Recall for ICU Medical Infusion Pump
A software flaw that may cause the Plum Duo Infusion System to become unresponsive has prompted a device correction, which the FDA has identified as its most serious recall type.
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Hamilton Medical Corrects C6 Ventilators Over Circuit Board Defect
The FDA has issued a Class I recall designation for the correction, which addresses a fault that can cause ventilation to stop unexpectedly.
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FDA Flags Defibrillator Lead Issue Linked to Serious Injuries, Deaths
Boston Scientific’s Endotak Reliance leads with ePTFE-coated coils may reduce shock efficacy due to coil calcification.
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Philips Respironics Updates Use Instructions for Certain BiPAP Devices
Updated guidance addresses ventilator inoperative alarm failures that may lead to therapy loss, with 13 injuries and eight deaths reported.
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FDA Issues Early Alert on Infusion Pump Issue from Baxter
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.
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BD Recalls Alaris Pump Modules Serviced With Previously Recalled Parts
The voluntary recall involves pump modules that may have been repaired with FR-110 bezels, which the company says can weaken over time and compromise safe infusion delivery.
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Recalls
Latest
SunMed Holdings Removes Adult Manual Resuscitator Devices
The Class I recall involves devices with incorrectly assembled B/V filters.
