Browse Device Recalls
969 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 969 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 969 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 28, 2016 | Merge Cardio software. Product Usage: Merge Cardio is a system intended... | If a reader selects Multi-study review prior to the original study completing its loading process... | Class II | Merge Healthcare, Inc. |
| Mar 28, 2016 | Merge Cardio software. Merge Cardio is a system intended to be used to ac... | If images are sent without an order in the system, they will be matched with the latest order on ... | Class II | Merge Healthcare, Inc. |
| Mar 28, 2016 | Merge PACS software. Merge PACS (Picture Archiving Communication System) ... | Cut lines on the image may present horizontally rather than vertically. | Class II | Merge Healthcare, Inc. |
| Mar 28, 2016 | Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and ... | Eye Station images were not importing properly and were imported under "unknown" due to an issue ... | Class II | Merge Healthcare, Inc. |
| Mar 28, 2016 | Merge PACS software. Product Usage: Merge PACS (Picture Archiving Commu... | The software did not show unviewed images when the last view was skipped. The physician may poten... | Class II | Merge Healthcare, Inc. |
| Mar 28, 2016 | Merge Hemo software. Merge Hemo monitors, measures, and records physiologic ... | There is a potential connection issue when powering up the Merge Hemo Record Station and the Hemo... | Class II | Merge Healthcare, Inc. |
| Mar 15, 2016 | GE Healthcare, Aisys and Aisys CS2. Intended to provide general inhalation... | The vacuum suction tubing could be kinked within the machine resulting in suction less than the 2... | Class II | GE Medical Systems, LLC |
| Mar 10, 2016 | The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a m... | If the PDM is utilized to output a pressure for computing fractional flow reserve (FFR), the anal... | Class II | Merge Healthcare, Inc. |
| Feb 17, 2016 | GE Healthcare, Aisys Carestation. | GE Healthcare has recently become aware of a potential safety issue involving a momentary, self-c... | Class II | GE Medical Systems, LLC |
| Feb 17, 2016 | GE Healthcare, Aisys CS2 anesthesia.. | GE Healthcare has recently become aware of a potential safety issue involving a momentary, self-c... | Class II | GE Medical Systems, LLC |
| Feb 10, 2016 | LightSpeed Plus (4-slice MDAS LightSpeed 4.0 CT Scanner System - The LightSp... | GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an... | Class II | GE Medical Systems, LLC |
| Feb 10, 2016 | LightSpeed QX/I (4-slice MDAS) LightSpeed 4.0 CT Scanner System - The Ligh... | GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an... | Class II | GE Medical Systems, LLC |
| Feb 10, 2016 | Discovery ST, , 2339985 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.... | GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an... | Class II | GE Medical Systems, LLC |
| Feb 10, 2016 | LightSpeed 16 (MDAS only , , 2339985 LightSpeed 4.0 CT Scanner System - The... | GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an... | Class II | GE Medical Systems, LLC |
| Feb 10, 2016 | LightSpeed Ultra (8-slice MDAS), 5120327-3 LightSpeed 4.0 CT Scanner Syste... | GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an... | Class II | GE Medical Systems, LLC |
| Feb 10, 2016 | Discovery LS, 2286327 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.... | GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an... | Class II | GE Medical Systems, LLC |
| Feb 9, 2016 | Merge Cardio software. The firm name on the label is Merge Healthcare, Hartl... | A report can be confirmed with the incorrect patient demographics resulting in it being saved und... | Class II | Merge Healthcare, Inc. |
| Feb 5, 2016 | Merge PACS software. The firm name on the label is Merge Healthcare, Inc., H... | When measuring a lesion on an unmagnified mammography image then performing the same measurement ... | Class II | Merge Healthcare, Inc. |
| Jan 31, 2016 | Merge OfficePACS software. The firm name on the label is Merge Healthcare, H... | Potential data loss occurs as a result of product archiving not working properly. | Class II | Merge Healthcare, Inc. |
| Jan 31, 2016 | RadSuite software. The firm name on the label is Merge Healthcare, Hartland,... | Potential for RadSuite AV viewer to skip image slices when the user presses page up or page down ... | Class II | Merge Healthcare, Inc. |
| Jan 30, 2016 | RadSuite software. The firm name on the label is Merge Healthcare, Hartland,... | Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (E... | Class II | Merge Healthcare, Inc. |
| Jan 30, 2016 | Merge Cardio software. Product Usage: Merge Cardio is an integrated car... | Patient information in the header is only found on the first page of the report and not on the su... | Class II | Merge Healthcare, Inc. |
| Jan 30, 2016 | Merge PACS software. The firm name on the label is Merge Healthcare, Hartlan... | A migrated study that has annotations will display the annotations, but when a prior study is loa... | Class II | Merge Healthcare, Inc. |
| Jan 30, 2016 | Merge OfficePACS software. The firm name on the label is Merge Healthcare, H... | Potential data loss occurs as a result of the software archiving not working properly. | Class II | Merge Healthcare, Inc. |
| Jan 30, 2016 | Merge PACS software. Product was distributed under the AMICAS label, Brighto... | The patient name in the Halo title bar and the thumbnails do not match the name on displayed images. | Class II | Merge Healthcare, Inc. |
| Jan 30, 2016 | iConnect Access used with Ortho PACS software provides medical specialists wi... | Studies that are viewed in iConnect Access that originate on Merge PACS / Ortho PACS may not disp... | Class II | Merge Healthcare, Inc. |
| Jan 30, 2016 | iConnect Access used with Merge PACS software provides medical specialists wi... | Studies that are viewed in iConnect Access that originate on Merge PACS / Ortho PACS may not disp... | Class II | Merge Healthcare, Inc. |
| Jan 30, 2016 | Merge PACS software. The firm name on the label is Merge Healthcare, Hartlan... | Studies coming over via telmed were missing patient's DOB, procedure, and referring physician. | Class II | Merge Healthcare, Inc. |
| Jan 30, 2016 | Merge FlexConnect software, a component of Merge LIS. Merge FlexConnect is m... | Communication protocols interfacing with the affected software version with some select instrumen... | Class II | Merge Healthcare, Inc. |
| 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. |
| 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 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 | 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. |
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.