Browse Device Recalls
3,013 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,013 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 3,013 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 10, 2016 | Fujifilm Synapse PACS software version 4.4.000, Fujifilm Synapse PACS softwa... | Synapse cannot display image files, DICOM SR files, and/or Annotation files. The "Image Not Load... | Class II | Fujifilm Medical Systems U.S.A., Inc. |
| May 9, 2016 | Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers... | Software error in previous software versions in which two references for the same image may exist... | Class II | Siemens Medical Solutions USA, Inc |
| May 6, 2016 | Ariol is an automated scanning microscope and image analysis system. It is in... | An issue during the manufacturing process caused systems to have an improperly activated Windows ... | Class III | Leica Biosystems Richmond Inc. |
| Apr 29, 2016 | Ingenuity Core128 Model No. 728323; To produce cross-sectional images of the... | Software issues in v4.1.3/4.1.4/4.1.5 in the Philips Ingenuity CT products that could affect the ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 29, 2016 | Brilliance iCT, Model No. 728306; To produce cross-sectional images of the b... | Software issues in versions v4.1 .3/4.1.5 in the Philips Brilliance iCT) iCT SP products that, co... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 29, 2016 | Ingenuity CT Model No. 728326; To produce cross-sectional images of the body. | Software issues in v4.1.3/4.1.4/4.1.5 in the Philips Ingenuity CT products that could affect the ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 29, 2016 | Ingenuity Core Model No. 728321; To produce cross-sectional images of the body. | Software issues in software versions v4.1.3/4.1.4/4.1.5 in the Philips Brilliance 64 and Ingenuit... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 29, 2016 | Brilliance iCT SP Model No. 728311; To produce cross-sectional images of the ... | Software issues found in v4.1 .3/4.1.5 in the Philips Brilliance iCT/ iCT SP products that could... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 29, 2016 | Brilliance 64 CT Model 728231; To produce cross-sectional images of the body. | Software issues found in software versions v4.1.3/4.1.4/4.1.5 in the Philips Brilliance 64 produ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 25, 2016 | Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v... | Volcano has become aware of an incompatibility issue between Impacted Systems and hospital networ... | Class II | Volcano Corporation |
| Apr 20, 2016 | MX 16-slice whole body computed tomography X-ray system. Imaging diagnostic t... | The following issues have been found in MX 16-slice systems with software version 1.1.4.21426: ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 20, 2016 | MX 16-slice SKD whole body computed tomography X-ray system. Imaging diagnos... | The following issues have been found in MX 16-slice systems with software version 1.1.4.21426: ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 15, 2016 | Merge LIS software. The firm name on the label is Merge Healthcare. Merge... | There are potential issues with results reporting for certain run-based tests. Under certain con... | Class II | Merge Healthcare, Inc. |
| Apr 15, 2016 | Given Imaging Bravo¿¿ pH capsule delivery device, 1-pack. In- Vitor Diagnost... | Potential of an allergic reaction in a patient with nickel sensitivity. | Class II | Covidien LLC |
| Apr 15, 2016 | Given Imaging Bravo¿ pH capsule delivery device, 5-pack. In-Vitro Diagnostic... | Potential of an allergic reaction in a patient with nickel sensitivity. | Class II | Covidien LLC |
| Apr 14, 2016 | CytoScan¿ Dx Assay. The CytoScan Dx Assay consists of five reagent modules, w... | During a recent Ohio site inspection by the FDA it was discovered that warning statements needed ... | Class III | Affymetrix Inc |
| Apr 13, 2016 | Merge Cardio software. The firm name on the label is Merge Healthcare, Hartl... | Fetal patient report was automatically pulling prior measurement data for a prior fetus since the... | Class II | Merge Healthcare, Inc. |
| Apr 12, 2016 | Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code: TSX-03... | Toshiba American Medical Systems, Inc. is recalling the TSX-035A because of a potential problem w... | Class II | Toshiba American Medical Systems Inc |
| Apr 11, 2016 | The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteu... | IBA is conducting a voluntary recall to address a PTS (Proton Therapy System) software issue and ... | Class II | Ion Beam Applications S.A. |
| Apr 11, 2016 | TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25... | Imaging system data may be displayed with an incorrect orientation (sidedness) where the patient ... | Class II | Echopixel, Inc. |
| Apr 8, 2016 | DR Systems Unity PACS software, now known as Merge Unity PACS | Reports were missing demographic header information when they were faxed to referring physicians. | Class II | Merge Healthcare, Inc. |
| Apr 8, 2016 | ROSA Surgical Device 2.5.8 | Potential for software to change the final tool orientation for the command position without comm... | Class II | Zimmer Biomet, Inc. |
| Apr 8, 2016 | ACUSON SC2000 Ultrasound imaging system with software version VB10C and using... | While imaging with a transesophageal (TEE) transducer (Z6Ms, V5Ms, or V7M), user may lose the abi... | Class II | Siemens Medical Solutions USA, Inc. |
| Apr 8, 2016 | DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usa... | The software is not adding the correct tomo image. | Class II | Merge Healthcare, Inc. |
| Apr 6, 2016 | Nuvectra, Algovita Spinal Cord Stimulation System Clinical Programmer, Model ... | If used, the optional Swap feature copies programming parameters from the external pulse generato... | Class II | Nuvectra |
| Apr 6, 2016 | VITROS 3600 Immunodiagnostic System, Catalog Number 6802783,for use in the in... | Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 ... | Class II | Ortho-Clinical Diagnostics |
| Apr 6, 2016 | VITROS 5600 Integrated System, Catalog Number 6802413, Unique Device Identifi... | Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 ... | Class II | Ortho-Clinical Diagnostics |
| Apr 4, 2016 | Merge Hemo software. Product Usage: Merge Hemo is a hemodynamic monitor... | In some instances, the system will lock tabs within a study, even when a second user does not hav... | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | iConnect Enterprise Archive software. | The versions allow images to be stored without pixel data, resulting in the system not being able... | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | iConnect Enterprise Archive (ICEA) software. iConnect Enterprise Archive is ... | The study is archived but cannot be opened in iConnect Access and cannot send to PACS resulting i... | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | Merge Cardio software. The firm name on the label is Merge Healthcare, Hartla... | When taking measurements from images on the Cardio workstation or from the US cart, numbers are n... | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | iConnect Enterprise Archive when used with RadSuite. The firm name on the la... | The software produced a number of "do not route" exceptions, which may result in potential pati... | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | Merge PACS software. The firm name on the label is Merge Healthcare. | Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol t... | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | Merge PACS software. The firm name on the label is Merge Healthcare, Hartlan... | Potential exists for an incorrect patient image being displayed which could result in the delay i... | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | Merge Cardio software using EchoIMS. The firm name on the label is Merge Hea... | A situation can occur allowing two physicians to access the same study report in EchoIMS when lau... | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | iConnect Enterprise Archive (ICEA) software. The firm name on the labeling i... | An error message can occur resulting in the prior studies being unavailable for viewing. | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | Merge Cardio software. | Cardio study list does not show STAT studies without refreshing. | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | Merge Hemo software. The firm name on the labeling is Merge Healthcare, Hart... | Use of the software may show an incorrect value to the user when viewing the Fractional Flow Rese... | Class II | Merge Healthcare, Inc. |
| Apr 4, 2016 | Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS,... | The system will completely stop allowing the downloading or acquisition of new images due to inco... | Class II | Merge Healthcare, Inc. |
| Apr 1, 2016 | Ingenuity Core-Computed Tomography X-ray system Product Usage: The Ingenu... | Philips Healthcare received reports from the field that certain Ingenuity Core systems running so... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 1, 2016 | Ingenuity Core 128-Computed Tomography X-ray system Product Usage: The In... | Philips Healthcare received reports from the field that certain Ingenuity Core128 systems running... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 1, 2016 | Brilliance 64, Computed Tomography X-ray system Product Usage: The Brilli... | Philips Healthcare received reports from the field that certain Brilliance 64 systems running sof... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 31, 2016 | Protura Robotic Couch System Software, versions 1.6.1 (Part Number MT6XSM1.6.... | When using the recalled product in split shift mode, the non-sub-millimeter positioning has been ... | Class II | Med Tec Inc |
| 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 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 25, 2016 | The Plum 360 is a large volume infuser capable of delivering fluids for a var... | Firm's investigation determined that the Proximal Occlusion Alarms observed in the field were att... | Class II | Hospira Inc. |
| Mar 25, 2016 | The Plum A+ is a dual-line volumetric infusion system designed to meet the gr... | Firm's investigation determined that the Proximal Occlusion Alarms observed in the field were att... | Class II | Hospira 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.