How Gaps in Requirements Traceability Fuel Recalls and Injuries
Breakdowns in linking requirements to design, risk, and verification are fueling software errors, compliance gaps, and costly recalls across device categories.
Tag: recalls
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GE HealthCare Updates EVair Compressor Recall for Ventilator Use
GE HealthCare has issued an update to the EVair Compressor recall, with testing results confirming safe usage across all patient groups.
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SonarMed Recalls Acoustic Airway Sensors
SonarMed Airway acoustic sensors were recalled for a restricted inner diameter, causing compatibility issues with suction catheters.
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How Gaps in Requirements Traceability Fuel Recalls and Injuries
Breakdowns in linking requirements to design, risk, and verification are fueling software errors, compliance gaps, and costly recalls across device categories.
Philips Stops Selling Respiratory Products in the U.S.
Philips announced that it would stop selling CPAP or BiPAP sleep therapy devices and other respiratory care devices in the U.S.
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Olympus Warns About Risk with Improper Bronchoscope Use
Olympus warned customers of issues involving use of certain bronchoscopes with high-frequency therapy equipment.
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Medical Device Recalls Fell 4.4% in Q2 2023
Medical device recalls fell 4.4% in Q2 2023 to 241 events, with quality concerns accounting for the majority of recalls.
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Cardiosave Hybrid and Rescue IABPs Recalled for Electrical Issues
Getinge recalled the Cardiosave Hybrid and Rescue IABPs because they may shut down unexpectedly due to electrical failure.
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Draeger Issues Recall for Carina Ventilators
Draeger initiated a voluntary recall notification for Draeger Carina Sub-Acute Care Ventilators to address a possible contamination issue.
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Baxter Finds Urgent Software Issue With Spectrum Infusion Pumps
Baxter announced an urgent issue with its Spectrum V8 and Spectrum IQ infusion pumps related to recent software updates.
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Abiomed Recalls Impella Left-Sided Blood Pumps
Abiomed issued the recall because the pumps’ instructions for use do not adequately address precautions to take when treating patients who have undergone transcatheter aortic valve replacement.
