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Browse Device Recalls

922 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 922 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 922 FDA device recalls in WI.

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DateProductReasonClassFirm
Mar 16, 2018 GE Healthcare: a) Prodigy, Model Numbers: LU7248, LU8905, LU40427, LU40431, ... Under certain conditions, when using DICOM Worklist along with DICOM MPPS, a report for a bone de... Class II GE Medical Systems Ultrasound & Primary Care Di...
Mar 16, 2018 GE Healthcare Lunar: a) DPX Duo, Model Number: LU41693 b) DPX Bravo, Model... Under certain conditions, when using DICOM Worklist along with DICOM MPPS, a report for a bone de... Class II GE Medical Systems Ultrasound & Primary Care Di...
Mar 16, 2018 GE Healthcare Lunar: a) DPX NT, Model Numbers: LU8230, LU40338, LU42357, LU... Under certain conditions, when using DICOM Worklist along with DICOM MPPS, a report for a bone de... Class II GE Medical Systems Ultrasound & Primary Care Di...
Feb 26, 2018 Cold Storage Solution, 2L, labeled as Waters IGL Cold Storage Solution, Catal... Bags of solution may have a small leak at the base of the injection port where the port is welded... Class II Preservation Solutions, Inc.
Feb 1, 2018 Nicolet¿ Ambulatory EEG Potential to be able to import an ambulatory exam for a patient for which the exam was not started. Class II Natus Neurology Inc
Jan 11, 2018 GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2 Th... CARESCAPE Central Station (CSCS) software version 2.0.2 units may experience unexpected NO COMM (... Class II GE Medical Systems Information Technologies, Inc.
Dec 27, 2017 EMS products from Graham Medical, SnugFit(R) Expandable Mattress Cover, Code ... The secondary supplier provided material was within specification but did not meet our design nee... Class II LITTLE RAPIDS CORPORATION
Dec 20, 2017 Disposable Drill Kit which includes two drill bits, two drill stops, and two ... There is a possibility that DDK2-2.4-30X Disposable Drill Kits, Lot Number 111664 208140649 conta... Class II Ad-Tech Medical Instrument Corporation
Dec 15, 2017 Uterine Electromyographic Monitor - Monica Novii Wireless Patch System Pro... if the cables of the Monica Novii System are removed by a user, and then incorrectly re-connected... Class II GE Healthcare, LLC
Dec 15, 2017 Uterine Electromyographic Monitor -Monica IF24 Interface System Product Us... if the cables of the Monica IF24 System are removed by a user, and then incorrectly re-connected ... Class II GE Healthcare, LLC
Dec 8, 2017 CARESCAPE R860 ventilators with software version 10SP05 Product Usage: Th... Potential for the display processor to experience an unexpected failure. Class II Datex-Ohmeda, Inc.
Nov 17, 2017 Hi-Art(R) System, Model Number H-000-0003 Product Usage: The TomoTherapy ... Uncontrolled couch Z-axis movement (descent) Class II Accuray Incorporated
Nov 17, 2017 TomoHD(R) System, Model Number 1018283 Product Usage: The TomoTherapy tre... Uncontrolled couch Z-axis movement (descent) Class II Accuray Incorporated
Nov 17, 2017 TomoH(R) System, Model Number 1018284 Product Usage: The TomoTherapy trea... Uncontrolled couch Z-axis movement (descent) Class II Accuray Incorporated
Nov 17, 2017 TomoHDA(R) System, Model Number 1018286 Product Usage: The TomoTherapy tr... Uncontrolled couch Z-axis movement (descent) Class II Accuray Incorporated
Oct 30, 2017 VariCam A potential hazardous situation may occur if the collimator locking handle is not properly placed... Class II GE Healthcare, LLC
Oct 30, 2017 Discover VH/Millennium VG Nuclear Medicine Imaging System A potential hazardous situation may occur if the collimator locking handle is not properly placed... Class II GE Healthcare, LLC
Oct 4, 2017 DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER Is designed for the metered deliv... Non-Conforming devices were shipped from the service center without proper evaluation and therefo... Class II GE Healthcare, LLC
Oct 4, 2017 DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used... Non-Conforming devices were shipped from the service center without proper evaluation and therefo... Class II GE Healthcare, LLC
Aug 14, 2017 Merge Unity software, formerly known as DR Systems Unity PACS software. The ... The software is not identifying the patient as having atypical hyperplasia, resulting in an incor... Class II Merge Healthcare, Inc.
Aug 7, 2017 Merge Unity software, formerly known as DR Systems Unity PACS software. The ... The software is not identifying the patient as having atypical hyperplasia, resulting in an incor... Class II Merge Healthcare, Inc.
Jul 13, 2017 CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitor... Device does not produce a visual or audible impedance respiration APN alarm when an impedance res... Class II GE Medical Systems Information Technologies, Inc.
Jun 13, 2017 Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution fo... When the user has not set up any user preference on the sorting order to render the study images ... Class II Merge Healthcare, Inc.
Jun 9, 2017 Nicolet¿ Elite¿ 2 MHz OB Water Proof Probe, Model #: X1L008, Catalog Code: NW... Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive backgr... Class II Natus Neurology Inc
Jun 9, 2017 Nicolet¿ Elite¿ 5 MHz Vascular Probe, Model #: X1L004, Catalog Code: N500. ... Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive backgr... Class II Natus Neurology Inc
Jun 9, 2017 Nicolet¿ Elite¿ 2 MHz OB Probe, Non-Fetal Monitor, Model #: X1L007, Catalog C... Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive backgr... Class II Natus Neurology Inc
Jun 9, 2017 Nicolet¿ Elite¿ 3 MHz OB Probe, Model #: X1L001, Catalog Code: N300. Inten... Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive backgr... Class II Natus Neurology Inc
May 24, 2017 Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Ha... Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol t... Class II Merge Healthcare, Inc.
May 24, 2017 Merge OrthoPACS software. A migrated study that has annotations will display the annotations, but when a prior study is loa... Class II Merge Healthcare, Inc.
May 19, 2017 GE Healthcare Discovery PET/CT 600,610, 690, 710: Optima PET/CT 560. 560FX ... It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 19, 2017 GE Healthcare Revolution EVO X-ray system It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 19, 2017 GE Healthcare Optima CT660, CT680 X-ray system It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 19, 2017 GE Healthcare Discovery NM/CT 670 CZT X-ray system It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 19, 2017 GE Healthcare Discovery Ml X-ray system It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 19, 2017 GE Healthcare Lightspeed RT16 X-ray system It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 19, 2017 GE Healthcare LightSpeed VCT X-ray system It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 19, 2017 GE Healthcare Optima CT580; Discovery RT, CT590 RT X-ray system It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 19, 2017 GE Healthcare Discovery IQ X-ray system It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 19, 2017 GE Healthcare Optima CT540 X-ray system It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 19, 2017 GE Healthcare Discovery Ml DR X-ray system It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 19, 2017 GE Healthcare Discovery NM/CT 670. 670 Pro, 670 ES X-ray system It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 19, 2017 GE Healthcare Discovery NM/CT 570c X-ray system It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 19, 2017 GE Healthcare BrightSpeed X-ray system It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 19, 2017 GE Healthcare lnnova IGS 540 ACT X-ray system It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 19, 2017 GE Healthcare Optima CT520 X-ray system It was discovered that an issue has been identified that can result in a scan starting before the... Class II GE Healthcare, LLC
May 11, 2017 Brivo MR355, Optima MR360 Product Usage: The Brivo MR355/Optima MR360 is ... Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potent... Class II GE Medical Systems, LLC
May 11, 2017 Signa PET/MR (K163619, K142098) Product Usage: The SIGNA PET/MR system co... Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potent... Class II GE Medical Systems, LLC
May 11, 2017 Discovery MR750 3.0T Product Usage: Intended use: The Discovery MR750 3.0... Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potent... Class II GE Medical Systems, LLC
May 11, 2017 SIGNA Creator, SIGNA ExplorerProduct Usage: 1.5T SIGNA Creator and 1.5T SIGN... Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potent... Class II GE Medical Systems, LLC
May 11, 2017 1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, ... Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potent... Class II GE Medical Systems, LLC

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.