BMC Medical Recalls APAP Devices Over Firmware Defect That Can Halt Therapy
The FDA classified the action as a Class I recall after the manufacturer determined that some devices may not have received a previous firmware upgrade.
Category: Recalls
Recalls
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Recalls
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FDA Issues Early Alert for Becton Dickinson Needle Sets Following Reports of Injuries and Deaths
The agency warns of a high-risk issue where needle components may lock during insertion, potentially delaying critical care.
Recalls
Latest
Philips Issues Correction for Trilogy Evo Ventilators Following FDA Class I Recall
The Food and Drug Administration identifies the software update and nebulizer restrictions as the most serious type of recall.
Recalls
Latest
BMC Medical Recalls APAP Devices Over Firmware Defect That Can Halt Therapy
The FDA classified the action as a Class I recall after the manufacturer determined that some devices may not have received a previous firmware upgrade.
FDA Issues Recall Early Alert for Olympus Single-Use Ligating Devices
Olympus has updated use instructions after reports that the ligation loop may not release as expected, potentially requiring emergency intervention.
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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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GE HeathCare Recalls Carestation Anesthesia Systems Due to Shutdown Risk
GE HealthCare is updating use instructions after reports certain systems may not switch to battery mode during AC power loss, potentially disrupting ventilation and agent delivery.
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Baxter Permanently Removes Life2000 Ventilation System Due to Cybersecurity Issue
The company is pulling the Life2000 system from the market after finding a vulnerability that could allow unauthorized changes to ventilation settings.
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NOxBOXi Delivery System Correction Issued After Reports of Nitric Oxide Dose Fluctuations
The FDA issued a safety alert after users reported nitric oxide dose fluctuations, potentially leading to hypoxemia or increased pulmonary artery pressure.
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Siemens Healthineers Corrects 3 Tesla MRI Systems Over Magnet Venting Blockage Risk
The issue affects certain systems in which ice may obstruct the venting system, potentially leading to dangerous overpressure events if a magnet quench occurs.
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Recalls
Latest
FDA Issues Recall Alert for B Braun Medical Hemodialysis Blood Tubing Set
The alert follows reports of damaged patient connectors that could introduce micro-air bubbles, trigger air-in-line alarms, and lead to treatment delays or blood loss during hemodialysis.
