Browse Device Recalls
93 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 93 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 93 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 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 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 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. |
| 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. |
| 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 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 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. |
| 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. |
| 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. |
| Apr 9, 2015 | Merge RadSuite software. Radiological image processing system. | When RadSuite is used with IPID (Issuer of Patient ID) as a part of the "Patient Identifier," it ... | Class II | Merge Healthcare, Inc. |
| Mar 30, 2015 | Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-000... | The units may display the alarm "sampling line clogged" after the flow zeroing procedure that is ... | Class II | Merge Healthcare, Inc. |
| Mar 5, 2015 | Merge LIS software. | There is a potential for duplicate container numbers to be created for patients. | Class II | Merge Healthcare, Inc. |
| Jan 21, 2015 | Merge Hemo, 9.10, 9.20.0, 9.20.1,9.20.2, 9.30, 9.40.0, 9.40.1, 9.40.2 with Ma... | A system freeze-up of the Merge Hemo system, that included the PHASEIN End Tidal CO2 unit, result... | Class II | Merge Healthcare, Inc. |
| Sep 29, 2014 | Merge Healthcare, Merge Hemo Programmable diagnostic computer. The system ... | It has been reported that during use, the SpO2 value displayed on the Hemo Monitor may not update... | Class II | Merge Healthcare, Inc. |
| Aug 28, 2014 | eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components ... | There is an issue related to eFilm Workstation versions 4.0 and 4.0.1 when having multiple studie... | Class II | Merge Healthcare, Inc. |
| Apr 30, 2014 | Merge Hemo software. Merge Hemo monitors, measures, and records physiolog... | The application may crash during the cath lab procedure. | Class II | Merge Healthcare, Inc. |
| May 6, 2013 | RadSuite software. The firm name on the label is Merge Healthcare, Hartland,... | Multiple studies were missing at a customer location that never made it to the archive before wat... | Class II | Merge Healthcare, Inc. |
| Nov 1, 2012 | CADstream software. Product Usage: CADstream is an image processing syst... | An incorrect biopsy or missed target could result if the incorrect grid is selected within the ap... | Class II | Merge Healthcare, Inc. |
| Jul 2, 2012 | Merge HEMO software. | The International Normalized Ratio (INR) value displayed in the study report does not match the v... | Class II | Merge Healthcare, Inc. |
| Oct 28, 2011 | Fusion Workstation.; Indicated for the transmission and review of radiologica... | After a period of time running Fusion Workstation, the Hounsfield measurement tool will report in... | Class II | Merge Healthcare, Inc. |
| Oct 19, 2011 | CADstream software Product Usage: CADstream is an image processing syst... | Customers may experience an issue with the software study preferences when changes are made to th... | 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.