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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.

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DateProductReasonClassFirm
Jun 19, 2013 GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System. The a... GE Healthcare has recently become aware of a potential safety issue with respect to Discovery IGS... Class II GE Healthcare, LLC
Jun 13, 2013 Discovery NM 630, dual detector free-geometry integrated nuclear imaging syst... GE became aware of an incident at a VA Medical Center facility in the US in which a patient died ... Class I GE Healthcare, LLC
Jun 13, 2013 GE Healthcare Infinia Hawkeye 4 Option For Dual-Head Variable Angle Gamma Cam... GE became aware of an incident at a VA Medical Center facility in the US in which a patient died ... Class I GE Healthcare, LLC
Jun 13, 2013 Brivo NM615, is an all-purpose, single detector integrated nuclear imaging sy... GE became aware of an incident at a VA Medical Center facility in the US in which a patient died ... Class I GE Healthcare, LLC
Jun 13, 2013 GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intend... GE became aware of an incident at a VA Medical Center facility in the US in which a patient died ... Class I GE Healthcare, LLC
Jun 13, 2013 Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging sy... GE became aware of an incident at a VA Medical Center facility in the US in which a patient died ... Class I GE Healthcare, LLC
Jun 13, 2013 Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is inten... GE became aware of an incident at a VA Medical Center facility in the US in which a patient died ... Class I GE Healthcare, LLC
Jun 13, 2013 Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera... GE became aware of an incident at a VA Medical Center facility in the US in which a patient died ... Class I GE Healthcare, LLC
Jun 11, 2013 The Centricity PACS Workstation is intended for use as a primary diagnostic a... GE has recently become aware of potential issues due to out of context issues associated with spe... Class II GE Healthcare It
May 14, 2013 Canister: CO2 canister with GE part numbers 1407-3200-000, 1407-7004-000, or ... GE Healthcare has recently become aware of a potential safety issue involving the reusable CO2 ab... Class II GE Healthcare, LLC
May 9, 2013 GE Healthcare, PET VCAR. PET VCAR application software is affected if inst... GE Healthcare has recently become aware of a potential safety issue with respect to the automated... Class II GE Healthcare, LLC
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.
May 2, 2013 GE Healthcare, Precision 500D Product Usage: The Precision 500D is design... GE Healthcare has recently become aware of a potential safety issue involving the overhead Video ... Class II GE Healthcare, LLC
Apr 19, 2013 Centricity Enterprise Archive is a software product for receiving, archiving ... GE Healthcare has become aware of a potential data loss issue associated with empty path names re... Class II Ge Healthcare It
Apr 10, 2013 The Discovery NM/CT 570c CT Standalone Scan The Discovery NM/CT 570c hybr... GE Healthcare has recently become aware of an incident where the wrong part of the patient body w... Class II GE Healthcare, LLC
Apr 9, 2013 GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the fol... GE Healthcare has recently become aware of a potential safety issue due to non-unique series iden... Class II GE Healthcare, LLC
Apr 3, 2013 GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage... GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ... Class II GE Healthcare, LLC
Apr 3, 2013 SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Health... GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ... Class II GE Healthcare, LLC
Apr 3, 2013 GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The int... GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ... Class II GE Healthcare, LLC
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

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.