Recall archive
353 recalls · page 1 of 15
Reported Sep 23, 2026
Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare
Matched: Brand — Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this…
5 more products in this recall
FDA (weekly enforcement report)
Reported Sep 2, 2026Updated Sep 7, 2026
Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand — Software issue may cause measurements to be displayed inaccurately.
FDA (openFDA device enforcement)
Reported Aug 12, 2026
GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems Information Technologies Inc.
Matched: Brand · Product · Product details — Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview or review screen might fail to close…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 12, 2026
Merge PACS, medical imaging diagnostic workstation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand — Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 22, 2026
Optima XR200amx, Mobile Digital-Ready Radiographic System
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 in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 1, 2026
GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems SCS
Matched: Brand · Product · Product details · Reason for recall — GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server…
FDA (openFDA device enforcement)
Reported Jun 24, 2026
Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models
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 of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 17, 2026
Allia IGS 3 Pulse angiographic X-ray system
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 of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 3, 2026
GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product Code SS9; used in conjunction with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems Information Technologies Inc.
Matched: Brand · Product · Product details · Reason for recall — GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server…
5 more products in this recall
FDA (openFDA device enforcement)
Reported May 20, 2026
Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300
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 of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart…
6 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 15, 2026
GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc.,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare Ireland Limited
Matched: Brand · Product · Product details — Presence of particulate matter
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Apr 8, 2026
SIGNA Premier systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare LLC
Matched: Brand — Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/serviced with…
FDA (openFDA device enforcement)
Reported Mar 11, 2026
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare
Matched: Brand · Product · Product details — Under certain workflows, patient information shown in the viewer may not match the images displayed on Centricity Universal Viewer Zero Footprint…
FDA (openFDA device enforcement)
Reported Jan 28, 2026
GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ge Medical Systems Israel, Functional Imaging
Matched: Brand · Product · Product details — There is a potential intermittent issue on certain Omni Legend systems that can result in a streaking artifact in the PET clinical scan images. This…
FDA (openFDA device enforcement)
Reported Jan 21, 2026
SMV DSX New Line, System, Tomography, Computed, Emission
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ge Medical Systems Israel, Functional Imaging
Matched: Brand · Reason for recall — GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 24, 2025
GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare GmbH
Matched: Brand · Product · Product details · Reason for recall — GE HealthCare has become aware that the Patient History tab in ViewPoint 6 versions 6.15.3 and 6.15.4 ultrasound software may not include complete…
FDA (openFDA device enforcement)
Reported Dec 24, 2025
GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222;…
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 — Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 19, 2025
Carescape B450, Model no. 5805686 - shipped with potentially affected batteries or affected batteries installed as a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare Finland Oy
Matched: Brand — Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 12, 2025
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B-K Medical A/S
Matched: Reason for recall — GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 29, 2025
Elscint Cardial; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ge Medical Systems Israel, Functional Imaging
Matched: Brand · Reason for recall — GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or…
13 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 29, 2025
GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5; Part Number 5867474-04;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wipro GE Healthcare Private Ltd.
Matched: Brand · Product · Product details — Carescape Central Station (CSCS), software version V3.0.5, can cause the system to enter a continuous reboot cycle. If this occurs, a loss of central…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 8, 2025
Change Healthcare Radiology Solutions software version 14.2.2
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Change Healthcare Canada Company
Matched: Brand · Product · Product details — Due to software issue, radiology reports may not be fully displayed when viewing.
FDA (openFDA device enforcement)
Reported Sep 10, 2025
Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand · Reason for recall — Merge Healthcare has been informed by Schiller AG (Baar, Switzerland) of an issue with the Schiller ARGUS PB-3000 Patient Data Module (PDM) where…
FDA (openFDA device enforcement)
Reported Sep 3, 2025
GE HealthCare OEC 9800.
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 non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically,…
1 more product in this recall
FDA (openFDA device enforcement)
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