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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Date	Product	Reason	Class	Firm
Jan 30, 2016	CADstream software. The firm name on the label is Merge Healthcare, Hartland...	The software was not presenting the PURE filter user interface message on DICOM transfer studies....	Class II	Merge Healthcare, Inc.
Jan 30, 2016	iConnect Enterprise Archive. The firm name on the label is Merge Healthcare, ...	Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (E...	Class II	Merge Healthcare, Inc.
Jan 14, 2016	9131-001 Defibrillation Electrodes, Lot No. 141125-02 Used in Powerheart G3 ...	Defibrillation electrodes may increase electrical impedance over time. If impedance becomes too h...	Class II	Cardiac Science Corporation
Dec 23, 2015	GE Healthcare, Optima XR200amx, Mobile Digital Ready Radiographic System ...	Potential safety latch mechanism failure. The safety latch, within the column that supports the ...	Class II	GE Medical Systems, LLC
Dec 23, 2015	GE Healthcare, Brivo XR285amx Mobile Digital Ready Radiographic System Des...	Potential safety latch mechanism failure. The safety latch, within the column that supports the ...	Class II	GE Medical Systems, LLC
Dec 23, 2015	GE Healthcare, Optima XR220amx, Mobile Digital Ready Radiographic System ...	Potential safety latch mechanism failure. The safety latch, within the column that supports the ...	Class II	GE Medical Systems, LLC
Dec 18, 2015	Mavig Monitor Suspension System, Model GD60, contained in the following Fluor...	GE Healthcare has recently become aware of a reported incident in which a Mavig suspension arm wi...	Class II	GE Medical Systems, LLC
Dec 18, 2015	NeoCoil 3.0T GEM Flex Coil. The 3.0T GEM Flex coil system includes three si...	Potential for higher than specified surface temperatures. Use of 3.0T GEM Flex system may result ...	Class II	NeoCoil, LLC
Dec 17, 2015	RadSuite, a picture archive and communications system. Model Numbers Versions...	Potential incorrect Standardized Uptake Values (SUV) measurements in RadSuite.	Class II	Merge Healthcare, Inc.
Dec 15, 2015	GE Healthcare, Aisys CS2,1011-9050-000; Avance Amingo,1009-9002-000, & Avanc...	The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open posit...	Class II	GE Medical Systems, LLC
Dec 15, 2015	Anesthesia device service kits. ASSY-MSN, VENT ENGINE ASSY, 1503-8101-000 ...	The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open posit...	Class II	GE Medical Systems, LLC
Dec 15, 2015	GE Healthcare, Aisys, 1011-9000-000. The GE Datex-Ohmeda Aisys Anesthesia ...	The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open posit...	Class II	GE Medical Systems, LLC
Dec 15, 2015	GE Healthcare, Aespire 7900, 1009-9012-000 & Aespire View, 1009-9212-000. ...	The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open posit...	Class II	GE Medical Systems, LLC
Dec 15, 2015	GE Healthcare, Aestiva 7900, 1006-9305-000. This version of the Datex-Ohmeda...	The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open posit...	Class II	GE Medical Systems, LLC
Dec 15, 2015	GE Healthcare, Aestiva MRI, 1006-9310-000. This version of the Datex-Ohmeda ...	The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open posit...	Class II	GE Medical Systems, LLC
Dec 7, 2015	GE Healthcare, 3.0T 6 Channel Phased Array Flex Coil, M0050SS. Product Us...	Coil overheating can occur when the device is used in Mode 2 setup. This could lead to a serious ...	Class II	GE Medical Systems, LLC
Dec 7, 2015	GE Healthcare, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2.	GE Healthcare has recently become aware of a potential safety issue with the 3.0T 6 Channel Flex ...	Class II	GE Medical Systems, LLC
Nov 17, 2015	Merge RadSuite software. The firm name on the label is Merge Healthcare, Har...	The values provided from the Pixel Value tool do not appear to be correct, which may result in po...	Class II	Merge Healthcare, Inc.
Nov 13, 2015	GE Healthcare Optima CL323i Product Usage: The angiographic X-ray system...	GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable ...	Class II	GE Medical Systems, LLC
Nov 13, 2015	GE Healthcare Optima IGS 320. Product Usage: The angiographic X-ray syste...	GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable ...	Class II	GE Medical Systems, LLC
Oct 26, 2015	Merge Cardio with software version 10.1 LA.	The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customer...	Class II	Merge Healthcare, Inc.
Oct 26, 2015	Merge Hemo with software versions 10.0 LA. Merge Hemo (formerly named Hear...	The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customer...	Class II	Merge Healthcare, Inc.
Oct 23, 2015	GE Healthcare, Revolution CT Scanners. Revolution CT- The system is inte...	GE Healthcare has recently become aware of a potential issue with routine head scans on your Revo...	Class II	GE Medical Systems, LLC
Oct 15, 2015	DR Systems Unity PACS software, now known as Merge Unity PACS software.	The software fails to associate to the correct MG image if there are two images for the same view.	Class II	Merge Healthcare, Inc.
Oct 8, 2015	Merge OrthoCase software. The firm name on the label is Merge Healthcare, H...	Measurements in the software are changing after saving a plan with a measurement result, which ma...	Class II	Merge Healthcare, Inc.
Oct 1, 2015	Merge Cardio software. Merge Cardio is a system intended to be used to ac...	Reporting feature times out after inactivity for more than an hour sending the user back to the s...	Class II	Merge Healthcare, Inc.
Sep 23, 2015	MR Surgical Suite II Table, Model Number(s): M8074SS, M8053SS, M0074SS. UP...	GE became aware of an issue with the table transfer release mechanism of the MR Surgical Suite Op...	Class II	GE Medical Systems, LLC
Sep 22, 2015	Merge Cardio software. Product Usage: Merge Cardio is a system intended...	Users can merge a device import file with an image study that already has a confirmed report, whi...	Class II	Merge Healthcare, Inc.
Sep 22, 2015	Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the...	For sites using the Issuer of Patient ID (IPID), the system will display the study list and image...	Class II	Merge Healthcare, Inc.
Sep 11, 2015	NicoletOne Software v5.94, Catalog/Part Number: 482-649600. The NicoletOne d...	When using the NicoletOne v5.94 software, after exiting the impedance check function and returnin...	Class II	Natus Neurology Inc
Aug 31, 2015	GE Healthcare, SIGNA 3.0T. Product Usage: Magnetic resonance system for di...	When performing head or neck scans, the currently displayed SAR values could be lower than the ac...	Class II	GE Healthcare
Aug 31, 2015	GE Healthcare, SIGNA PET/MR 3.0T. Product Usage: The SIGNA PET/MR system...	When performing head or neck scans, the currently displayed SAR values could be lower than the ac...	Class II	GE Healthcare
Aug 31, 2015	GE Healthcare, SIGNA HDx 3.0T. Product Usage: The GE Signa HDx MR system is a...	When performing head or neck scans, the currently displayed SAR values could be lower than the ac...	Class II	GE Healthcare
Aug 31, 2015	GE Healthcare, SIGNA HD 3.0T. Product Usage: The Signa Profile EXCITE MR syst...	When performing head or neck scans, the currently displayed SAR values could be lower than the ac...	Class II	GE Healthcare
Aug 31, 2015	GE Healthcare, SIGNA HDxt 3.0T. Product Usage: The 1.5T Signa HDx family ...	When performing head or neck scans, the currently displayed SAR values could be lower than the ac...	Class II	GE Healthcare
Aug 31, 2015	GE Healthcare, SIGNA Excite 3.0T. MR System for use as a diagnostic imaging ...	When performing head or neck scans, the currently displayed SAR values could be lower than the ac...	Class II	GE Healthcare
Aug 31, 2015	GE Healthcare, Discovery MR750w 3.0T. Product Usage: The Discovery MR750 ...	When performing head or neck scans, the currently displayed SAR values could be lower than the ac...	Class II	GE Healthcare
Jul 23, 2015	Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems PACS) is a...	The software is unable to accurately determine the calcium score of scans with a slice thickness ...	Class II	Merge Healthcare, Inc.
Jul 20, 2015	Titan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the En...	Titan Spine is recalling specific Endoskeleton TCS Integrated Locking Bone Screw Assembly due to ...	Class II	TITAN SPINE, LLC
Jul 17, 2015	PET Discovery ST 16	Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Di...	Class II	GE Healthcare
Jul 17, 2015	PET Discovery LS	Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Di...	Class II	GE Healthcare
Jul 17, 2015	Lightspeed 16 CT	Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Di...	Class II	GE Healthcare
Jul 10, 2015	GE Healthcare, Signa Infinity MR System; Signa MR/i MR System; SmartSpeed; Ec...	A gradient cable in the ACGD cabinet may be missing a spacer that prevents connecting the gradien...	Class II	GE Healthcare
Jun 12, 2015	GE Healthcare, Precision MPi fluoroscopic imaging systems.	A reported incident of a monitor that fell from the suspension. A fall of a monitor could result...	Class II	GE Healthcare
Jun 12, 2015	GE Healthcare Precision RXi Digital system	A reported incident of a monitor that fell from the suspension. A fall of a monitor could result...	Class II	GE Healthcare
Jun 12, 2015	GE Healthcare Precision RXi 23A/32A Analog System	A reported incident of a monitor that fell from the suspension. A fall of a monitor could result...	Class II	GE Healthcare
Jun 12, 2015	GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Flu...	The SFD/IDD safety mechanism may not engage properly at the lower range of SFD/IDD travel. This m...	Class II	GE Healthcare
Jun 12, 2015	GE Healthcare Precision 500D Classical R & F system.	A reported incident of a monitor that fell from the suspension. A fall of a monitor could result...	Class II	GE Healthcare
May 31, 2015	The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2...	Non-invasive blood pressure pumps (NIBP) voltage is not sufficient and causes the NIBP pumps to f...	Class II	Merge Healthcare, Inc.
May 29, 2015	GE Healthcare Innova 3131IQ. Angiographic X-ray systems used in generating...	GE Healthcare has recently become aware of a potential safety issue that may result in the loss o...	Class II	GE Healthcare

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.