Recall archive
353 recalls · page 2 of 15
Reported Aug 20, 2025
GE Signa Artist, Nuclear Magnetic Resonance Imaging System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
Matched: Brand · Product · Product details · Reason for recall — GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect,…
21 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 30, 2025
SIGNA Architect
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
Matched: Brand · Reason for recall — GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 9, 2025
Change Healthcare Cardiology Hemo Software
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Change Healthcare Canada Company
Matched: Brand · Product · Product details — Due to complaints, software update may cause software to unexpectedly shutdown.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 2, 2025
GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems China Co., Ltd.
Matched: Brand · Product · Product details · Reason for recall — GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 18, 2025
MUSE 5 Systems, Model Numbers 2021274-001, 2023032-005, 2027478-001, Large capacity client-server-based computer system…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems Information Technologies Inc.
Matched: Brand · Reason for recall — The MUSE Administrator Account active directory or local credential could potentially be used from your local network to log into a GE HealthCare…
FDA (openFDA device enforcement)
Reported May 7, 2025
GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000. anesthesia systems
High riskUsing this product could cause serious injury, illness or death — stop using it now.GE Medical Systems China Co., Ltd.
Matched: Brand · Product · Product details — Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV)…
14 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 9, 2025
GE Healthcare Centricity Universal Viewer (UV), Model Numbers: 1) 2066908-077; 2) 2066908-136; 3) 2066908-150; 4)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare
Matched: Brand · Product · Product details — There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), &…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 26, 2025
VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8; VERICIS is an integrated…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand — When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 19, 2025
GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
Matched: Brand · Product · Product details · Reason for recall — GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product…
6 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 5, 2025
SIGNA Creator, SIGNA Explorer, NMRI systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare (China) Co., Ltd.
Matched: Brand — For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2025
GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4) H3000YG; System, Tomography,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ge Medical Systems Israel, Functional Imaging
Matched: Brand · Product · Product details · Reason for recall — GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear…
12 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 15, 2025
GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-3; 2) 5555000-4: 3) A0659MB
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
Matched: Brand · Product · Product details · Reason for recall — GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the…
7 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 11, 2024
GE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomography systems labeled as:
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare (China) Co., Ltd.
Matched: Brand · Product · Product details · Reason for recall — GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades…
16 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 4, 2024
GE Proteus XR/A radiographic system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare (China) Co., Ltd.
Matched: Brand · Product · Product details · Reason for recall — Steel cables in the Wall Stand for certain Proteus XR/a systems serviced by GE HealthCare have not been replaced at the intervals detailed in the…
FDA (openFDA device enforcement)
Reported Nov 13, 2024
GE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers: 1) 2089507-083, GDZH-JINWAN-Centricity 2)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare
Matched: Brand · Product · Product details · Reason for recall — GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (ZFP) where there is a potential security…
FDA (openFDA device enforcement)
Reported Nov 6, 2024
GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and infant warmer. Model Numbers: 1)…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Datex--Ohmeda, Inc.
Matched: Product · Product details — Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from newly manufactured incubators could be…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 23, 2024
Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3, 15.0.1, 15.1.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Change Healthcare Canada Company
Matched: Brand · Product · Product details · Reason for recall — A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data entry can lead to inaccurate hemodynamic…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 23, 2024
GE Heathcare Giraffe OmniBed; neo natal incubator
High riskUsing this product could cause serious injury, illness or death — stop using it now.Datex--Ohmeda, Inc.
Matched: Product · Product details · Reason for recall — GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices, the screw that secures the doors that cover…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 16, 2024
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/Code Numbers: a)¿¿¿¿¿ 2089507-120;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare
Matched: Brand · Product · Product details · Reason for recall — GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (ZFP) version v6.0 SP11.x where the latest report is…
FDA (openFDA device enforcement)
Reported Oct 2, 2024
GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare
Matched: Brand · Product · Product details · Reason for recall — GE HealthCare has become aware of an issue where image storage is not possible when Centricity PACS reaches the maximum number of unique image…
FDA (openFDA device enforcement)
Reported Oct 2, 2024
GE Giraffe Warmer, Model/Catalog Number M1118179-01090979. Infant radiant warmers provide infrared heat in a controlled…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wipro GE Healthcare Private Ltd.
Matched: Brand · Product · Product details · Reason for recall — GE HealthCare has become aware that complete electrical safety testing was not conducted during manufacturing of certain Giraffe and Panda iRes…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 25, 2024
ViewPoint; system, imaging processing, radiological
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare GmbH
Matched: Brand · Reason for recall — The National Institute of Standards and Technology (NIST) has identified in the National Vulnerability Database (NVD) that NexGen Healthcare Mirth…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 25, 2024
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: a) 2110344-008; b) 2110344-009; c)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare
Matched: Brand · Product · Product details — Footprint Client (ZFP) versions v6.0 SP9.x and SP10.x where the latest addended report is not shown by default to the user. The issue occurs when the…
FDA (openFDA device enforcement)
Reported Sep 4, 2024
GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999; 4)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare (China) Co., Ltd.
Matched: Brand · Product · Product details — The XR system, Proteus XR/a, does not have a de-installation manual describing process steps for de-installing the devices. De-installation…
FDA (openFDA device enforcement)
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