Browse Device Recalls
1,000 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,000 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 1,000 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 28, 2013 | Optima MR430s MRI Scanner; 5000-0002 is indicated to use as a magnetic res... | Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard. | Class II | GE Healthcare, LLC |
| Mar 28, 2013 | MSK EXTREME MR SCANNER, MODEL AA5000 The intended for use as a diagnostic ... | Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard. | Class II | GE Healthcare, LLC |
| Mar 26, 2013 | GE PET Discovery 610, PET Discovery 710. Intended for head and whole body ... | GE Healthcare has recently become aware of a potential safety issue related with the DMPR functio... | Class II | GE Healthcare, LLC |
| Mar 26, 2013 | GE, Optima CT660. Intended to produce cross-sectional images of the body b... | GE Healthcare has recently become aware of a potential safety issue related with the DMPR functio... | Class II | GE Healthcare, LLC |
| Mar 12, 2013 | The Centricity Laboratory System is intended to be an information system desi... | GE Healthcare has become aware of a potential safety issue associated with the use of GE Centrici... | Class II | GE Healthcare It |
| Mar 12, 2013 | The Centricity Laboratory System is intended to be an information system desi... | GE Healthcare is aware of a potential safety issue with the use of GE Centricity Laboratory Instr... | Class II | GE Healthcare It |
| Mar 11, 2013 | Centricity Perinatal and Centricity Intensive Care is intended to be used in ... | 1) Under rare network conditions, a Centricity Perinatal process may maintain an incorrect count ... | Class II | GE Healthcare It |
| Feb 18, 2013 | Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 1... | A software defect was discovered that causes images to be out of context with clinical information. | Class II | Ge Healthcare It |
| Feb 18, 2013 | Centricity PACS Web Diagnostic (WebDX) by GE Healthcare Dynamic Imaging Solut... | It was reported from a complaint that study category labels of "Prior" and "Baseline" and hanging... | Class II | Ge Medical Systems Information T |
| Feb 18, 2013 | The Centricity PACS Workstation is intended for use as a primary diagnostic a... | Using Merge Exam in single Study Mode may result in Missing Study Record (Cannot Display Exam, Se... | Class II | GE Healthcare |
| Feb 8, 2013 | GE Healthcare LOGIQ S8 (with software revisions R1.1.1 and R1.5.1) and LOGIQ ... | GE Healthcare has become aware of a potential safety issue due to the S4-10-D Ultrasound Probe us... | Class II | GE Healthcare, LLC |
| Jan 21, 2013 | GE Healthcare Advantx, Innova2000, Innova3100, Innova4100, Innova2100IQ, Inn... | A locking nut might loosen out of the overhead Video Monitor Suspension yoke affecting Advantx, I... | Class II | GE Healthcare, LLC |
| Jan 14, 2013 | GE Healthcare Senographe Essential System. The Senographe 2000D system gen... | GE Healthcare has recently become aware of a potential issue due to inaccessible Operator Instruc... | Class II | GE Healthcare, LLC |
| Jan 9, 2013 | Ventri Discovery NM 530c, Ventri with Premium Table Discovery NM 530c, models... | GE Healthcare has recently become aware of an incident which caused a patient injury during an un... | Class II | GE Healthcare, LLC |
| Jan 8, 2013 | Giraffe OmniBed¿ and Giraffe Incubator p/n 6600-0723-700 (rev A and B) label... | Neonatal beds and incubator display boards may randomly overwrite stored information and radiant ... | Class I | GE Healthcare, LLC |
| Nov 20, 2012 | The Centricity Laboratory System is intended to be an information system desi... | If environment variables MICRO_CORRECT_MSG_TYPE and CORRECT_MSG_TYPE are set to different value... | Class II | GE Healthcare It |
| Nov 20, 2012 | The Centricity Laboratory System is intended to be an information system desi... | GE Healthcare is aware of a potential safety issue associated with the use of GE Centricity Labor... | Class III | GE Healthcare It |
| Nov 20, 2012 | Centricity Laboratory Core Lab System 4.1 The Centricity Laboratory System... | The Centricity Laboratory removes free-text notes on a master panel when the user deletes the sla... | Class II | GE Healthcare It |
| Nov 16, 2012 | Centricity Enterprise Archive is a software product for receiving, archiving ... | There is a potential for data loss associated with empty path names resulting from HL-7 updates w... | Class II | Ge Healthcare It |
| Nov 15, 2012 | GE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x Picture Ar... | While merging exams in a test instance, merges carry forward in the production system, when the m... | Class II | GE Healthcare It |
| Nov 9, 2012 | GE Healthcare, LOGIQ e Ultrasound System. The LOGIQ i/e and Vivid e is a ... | GE Healthcare became aware of a potential issue associated with the LOGIQ e system. Image data fr... | Class II | GE Healthcare, LLC |
| 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. |
| Oct 16, 2012 | Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 A fetal s... | Thirty fetal scalp electrodes were found to have an incomplete package seal and lacked the printe... | Class II | Vital Signs Devices, a GE Healthcare Company |
| Oct 15, 2012 | GE Healthcare - Giraffe and Panda T-Piece Resuscitation System The T-piece... | Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed d... | Class I | GE Healthcare, LLC |
| Oct 15, 2012 | Giraffe and Panda Bag and Mask Resuscitation System The T-piece Resuscitat... | Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed d... | Class I | GE Healthcare, LLC |
| Oct 12, 2012 | GE Discovery NM/CT670; GE Discovery NM 630 Product Usage: a medical too... | GE Healthcare has recently become aware of a potential safety issue associated with the table pa... | Class II | GE Healthcare, LLC |
| Oct 2, 2012 | Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Commun... | GE Healthcare is aware of a potential safety risk where an image labeling situation exists in the... | Class II | GE Healthcare It |
| Sep 26, 2012 | GE Healthcare Definium 5000/5220493-2 X-Ray System | When quickly switching the protocols from AEC to Fixed under the same view, if the user selection... | Class II | GE Healthcare, LLC |
| Sep 26, 2012 | GE Healthcare Definium 5000 / 5220493 X-Ray System | When quickly switching the protocols from AEC to Fixed under the same view, if the user selection... | Class II | GE Healthcare, LLC |
| Sep 20, 2012 | GE Healthcare Optima 200amx Mobile general purpose radiographic imaging of... | It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic p... | Class II | GE Healthcare, LLC |
| Sep 20, 2012 | GE Healthcare Optima XR 200amx with digital upgrade Mobile general purpose... | It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic p... | Class II | GE Healthcare, LLC |
| Sep 20, 2012 | GE Healthcare Optima XR 220amx Mobile general purpose radiographic imaging... | It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic p... | Class II | GE Healthcare, LLC |
| Sep 20, 2012 | GE Healthcare, Seno Advantage, 5183685, 5183685-2, 5183685-3, 5183685-4, 5183... | GE Healthcare has recently become aware that patient mismatch without a warning message could occ... | Class II | GE Healthcare, LLC |
| Sep 20, 2012 | GE Healthcare Brivo XR 285 Mobile general purpose radiographic imaging of ... | It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic p... | Class II | GE Healthcare, LLC |
| Sep 15, 2012 | Centricity PACS System versions 3.X and higher and 4.X and higher Product Us... | There is a potential loss of image(s) associated with the Centricity to Centricity (C2C) exam tra... | Class II | Ge Healthcare It |
| Aug 16, 2012 | GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging syst... | GE Healthcare has recently become aware of a potential safety issue with respect to the Innova 21... | Class II | GE Healthcare, LLC |
| Aug 13, 2012 | GE Healthcare, LOGIQ S8 Ultrasound System The device is intended for use ... | GE Healthcare became aware of a potential issue related to incorrect image measurement associated... | Class II | GE Healthcare, LLC |
| Aug 7, 2012 | GE Healthcare, Optima XR220amx, Optima XR200amx, and Brivo XR285amx. The s... | GE Healthcare conducted a recall on various mobile x-ray units (Optima XR220amx, Optima XR200amx,... | Class II | GE Healthcare, LLC |
| Aug 3, 2012 | GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System | GE Healthcare has become aware of a software issue on the interface of the Brivo XR385 DR-F/ Mode... | Class II | GE Healthcare, LLC |
| Aug 1, 2012 | GE Healthcare Optima XR 220amx 15kw Mobile X-Ray System The GE Automatic M... | GE Healthcare has become aware of a software issue on the interface of the mobile radiographic pr... | Class II | GE Healthcare, LLC |
| Aug 1, 2012 | GE Healthcare Optima XR 200 amx with Digital Upgrade. The GE Automatic Mob... | GE Healthcare has become aware of a software issue on the interface of the mobile radiographic pr... | Class II | GE Healthcare, LLC |
| Aug 1, 2012 | GE Healthcare Optima XR 220amx 30kw Mobile X-ray System The GE Automatic M... | GE Healthcare has become aware of a software issue on the interface of the mobile radiographic pr... | Class II | GE Healthcare, LLC |
| Jul 20, 2012 | CARESCAPE Monitor B850 Product Usage: The CARESCAPE TM Monitor B850 is ... | GE Healthcare become aware of 4 potential issues associated with the CARESCAPE Monitor B850. The... | Class II | GE Healthcare, LLC |
| Jul 13, 2012 | GE Healthcare, VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM. ... | GE Healthcare has recently become aware that during use of the Voluson E6 or E8 systems, that an ... | Class II | GE Healthcare, LLC |
| Jul 12, 2012 | GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a mul... | GE Healthcare has recently become aware of a number of potential issues associated with the CARE... | Class II | GE Healthcare, LLC |
| Jul 10, 2012 | Optima XR200amx. Mobile general purpose radiographic imaging of the human he... | Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects... | Class II | GE Healthcare, LLC |
| Jul 10, 2012 | Optima XR220amx Mobile general purpose radiographic imaging of the human h... | Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects... | Class II | GE Healthcare, LLC |
| 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. |
| Jun 28, 2012 | GE Healthcare, AW Server. Product Usage: . AW Server is a medical softwar... | GE Healthcare has recently become aware of a potential safety issue with respect to the Results V... | Class II | GE Healthcare, LLC |
| Jun 26, 2012 | GE Healthcare, Dash 3000/4000/5000. The Dash 3000/4000/5000 patient monito... | GE Healthcare has recently become aware of a potential issue due to an unexpected loss of Custom ... | Class II | GE Healthcare, 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.