Recall archive
353 recalls · page 3 of 15
Reported Aug 14, 2024
SIGNA Architect, with affected software versions: DV26.0 to DV26.3, DV27.0 to DV27.3, DV28.0 to DV28.5, DV29.0, DV29.1,…
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 for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when…
25 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 17, 2024
GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB; b) Vivid E95, H45581DA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Vingmed Ultrasound As
Matched: Brand · Product · Product details · Reason for recall — GE HealthCare has become aware of an issue with certain Vivid ultrasound systems where, due to a slow DICOM Worklist response time, incorrect patient…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 3, 2024
CARESCAPE Canvas 1000, Model Numbers: a) 5865770; b) 5865770-01040169; c) 5865770-01054142; d) 5865770-01054696; e)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare Finland Oy
Matched: Brand · Reason for recall — GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 12, 2024
GE HealthCare CRITIKON ONE-CUF blood pressure cuffs, Model numbers: 1. ONE-A1-1B, ONE-CUF, SMALL ADULT, 1 TB BAYONET,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems Information Technologies Inc.
Matched: Brand · Product · Product details — Use of the blood pressure cuffs could result in inaccurate non-invasive blood pressure measurements.
FDA (openFDA device enforcement)
Reported May 15, 2024
GE Healthcare Innova IGS 5, computed tomography x-ray 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 the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery…
6 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 21, 2024
GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000, e)…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Wipro GE Healthcare Private Ltd.
Matched: Brand · Product · Product details · Reason for recall — GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 7, 2024
EVair air compressor, model numbers: M1230849 and M1230847
High riskUsing this product could cause serious injury, illness or death — stop using it now.Datex-Ohmeda, Inc.
Matched: Reason for recall — GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compressors are used with the…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 7, 2024
GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ge Healthcare Austria GmbH & Co.
Matched: Brand · Product · Product details · Reason for recall — GE HealthCare has become aware of an issue with certain IC9-RS ultrasound probes (see Affected Products List) that can result in a double image…
FDA (openFDA device enforcement)
Reported Dec 20, 2023
Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Change Healthcare Canada Company
Matched: Brand · Product · Product details — Under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share systems has been incorrectly associated with…
FDA (openFDA device enforcement)
Reported Dec 20, 2023
The System is designed as a modular system with components that include an Overhead Tube Suspension with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Hangwei Medical Systems, Co. Ltd.
Matched: Brand · Reason for recall — GE HealthCare has become aware of the potential that incorrect torque has been applied to certain bolts of the Definium Tempo and Definium Tempo Pro…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 15, 2023
Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information management…
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 — Change Healthcare has identified a software issue where Change Healthcare Radiology Solutions 14.0, 14.1, and 14.2 may not update records in external…
FDA (openFDA device enforcement)
Reported Nov 1, 2023
Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiological Image Processing System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare
Matched: Brand · Reason for recall — GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 19, 2023
GE Healthcare Vivid S60, ultrasound device
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Vingmed Ultrasound As
Matched: Brand · Product · Product details · Reason for recall — GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If this occurs, it can delay availability of…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 12, 2023
Giraffe OmniBed Carestation CS1, Model Numbers: a. 2082844-001-XXX, b. 2074920-001-XXXXXX, c. M1050205, d. M1135822, e.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Datex--Ohmeda, Inc.
Matched: Reason for recall — GE HealthCare has become aware of the potential that an incorrect type of secondary latch could have been installed on the northeast (NE) and/or…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 12, 2023
TruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs; b) REF TS-AP-25, 25 pcs
High riskUsing this product could cause serious injury, illness or death — stop using it now.GE Healthcare Finland Oy
Matched: Brand — There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement.
8 more products in this recall
FDA (openFDA device enforcement)
Reported May 10, 2023
Centricity PACS-IW with Universal Viewer, Model/Catalog Numbers: a) 2066908-061, b) 2066908-077, c) 2066908-086, d)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare
Matched: Brand · Reason for recall — GE HealthCare has become aware of an issue where information from two different patients can be mismatched when correcting patient or study…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 28, 2022
Centricity PACS-IW with Universal Viewer version 5.0. Used to display medical images (Including mammograms) and data…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
Matched: Brand · Reason for recall — There is the potential that after installation of the IAS tool, some studies can remain hidden without user notification. Access to those hidden…
14 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 21, 2022
Iohexol (300 mg Iodine/mL), 2.4 g Iodine/8 ml, Total Volume 8 ml in 10 ml syringe, 5-count syringes packaged in a bag…
High riskUsing this product could cause serious injury, illness or death — stop using it now.BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy
Matched: Product details — Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL
FDA (openFDA drug enforcement)
Reported Aug 31, 2022
(1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details — Inaccurate Distance and Area measurements with use of Global Stack viewport.
FDA (openFDA device enforcement)
Reported Aug 17, 2022
Service manuals for the CT, PET, or NM table as follows: GT1700/GT1700V/VT1700, GT2000/VT2000, GT2000x/VT2000x, High…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — As a result of unclear guidance in the service manual, the table can drop during a specific service activity if the wrong screws are removed by the…
FDA (openFDA device enforcement)
Reported Aug 3, 2022
Centricity PACS Software Version 7.0 SP0.0.4.7
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post…
FDA (openFDA device enforcement)
Reported Jul 27, 2022
GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia…
High riskUsing this product could cause serious injury, illness or death — stop using it now.GE Healthcare, LLC
Matched: Brand · Product · Product details — There is a potential reversal of the O2 and air cylinder pressure transducer connections.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 13, 2022
GE Centricity Universal Viewer Zero Footprint. To view, communicate, process, and display Medical images and data…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details — Potential to display inaccurate measurements on images in Centricity Universal Viewer Zero Footprint Client (ZFP)
FDA (openFDA device enforcement)
Reported Jul 6, 2022
Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or after April 1, 2019
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — Backup batteries can fail earlier than their estimated life.
1 more product in this recall
FDA (openFDA device enforcement)
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