Software problems medical devices recalls
20 FDA Class I medical devices recall events since Jan 1, 2025 whose stated reason matches “Software problems”. Grouping is by keyword in FDA's reason text — see methodology.
Recalls
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Nova Biomedical Corporation medical device recall: StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose…
A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously…
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Abiomed, Inc. medical device recall: Automated Impella Controller
Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.
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Fresenius Kabi USA, LLC medical device recall: LVP software of the Ivenix Infusion System
Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the…
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North American Rescue LLC. medical device recall: AIDBAGs are first aid kits of convenience composed of individually…
Kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that has been recalled for an issue with the software design of the E-5 Error Code…
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Boston Scientific Corporation medical device recall: Boston Scientific Pacemaker
Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers…
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Olympus Corporation of the Americas medical device recall: Olympus High Flow Insufflation Unit. Model Number: UHI. Used for…
Issue with software algorithm which may lead to overpressure events.
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Fresenius Kabi USA, LLC medical device recall: Ivenix Infusion System
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
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Tandem Diabetes Care, Inc. medical device recall: Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps…
Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or malfunctions. Pump may exhibit false vibration motor failure due to a…
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Dexcom, Inc. medical device recall: Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product…
A software defect in version v1.15.0 of the G6 Android app can cause the app to terminate unexpectedly, which may result in the user not receiving estimated glucose…
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Boston Scientific Corporation medical device recall: Accolade Sr Sl
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for…
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mo-Vis BVBA medical device recall: Micro Joystick R-net. Electrical wheelchair component
Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the…
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Baxter Healthcare Corporation medical device recall: Novum IQ LVP
Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software…
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Dexcom, Inc. medical device recall: Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product…
The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and…
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Baxter Healthcare Corporation medical device recall: Baxter SIGMA Spectrum Infusion Pump V6
Certain Spectrum infusion pumps may have an incorrect version of software.
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Zyno Medical LLC medical device recall: Z-800 Infusion System. Intended to provide intravenous infusion of…
Unreleased software versions were installed on distributed devices without verification or validation.
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Tandem Diabetes Care, Inc. medical device recall: t:slim X2 Insulin Pump with Interoperable Technology
A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to…
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CareFusion 303, Inc. medical device recall: BD Alaris Systems Manager
Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).
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Fresenius Kabi USA, LLC medical device recall: Ivenix Infusion System
Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: 1. The pump may become nonfunctional if during an alarm condition the…
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Braemar Manufacturing, LLC medical device recall: Monitoring Service Application
Not all Electrocardiogram (ECG) events received July 2022-July 2024 were not properly routed and subsequently reviewed due to an analysis step being disabled with the…
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Nova Biomedical Corporation medical device recall: StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685.…
A software bug within the Gen 2 StatStrip Hospital Meter firmware leads to transmission of erroneous glucose patient test results to a healthcare institution's data…