Recall archive
353 recalls · page 4 of 15
Reported Jun 22, 2022
CARESCAPE Central Station (CSCS) V2, Model numbers 2082278-001 and 2082279-001. Update 3/10/2023: The following FRU and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — The CARESAPE Central Station (CSCS) V2 can shut down due to a potential power supply component failure. This can lead to loss of patient monitoring…
FDA (openFDA device enforcement)
Reported Jun 15, 2022
Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM…
High riskUsing this product could cause serious injury, illness or death — stop using it now.GE Healthcare, LLC
Matched: Brand — Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.
6 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 27, 2022
GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details — During the de-installation of an MR system magnet, if all rigging and hardware that attach to the magnet for transportation are not properly…
FDA (openFDA device enforcement)
Reported Apr 20, 2022
MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — Two scenarios may cause edits to measurements and diagnosis statements can be lost after a test is Signed in the MUSE NX web client.
FDA (openFDA device enforcement)
Reported Apr 13, 2022
Revolution Apex, Revolution CT with Apex Edition
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 23, 2022
GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700 (Desktop, REF…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details — If the CARESCAPE Central Station v2.0 is used with an unapproved keyboard, the audio can be muted resulting in loss of audible alarms.
FDA (openFDA device enforcement)
Reported Feb 16, 2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Premier System, nuclear magnetic resonance…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details — The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
31 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 2, 2022
GE Vscan Extend, being sold as "Vscan Extend Console"
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details — The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to…
6 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 8, 2021
GE Centricity Universal Viewer Zero Footprint Client
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details — There is a potential to display incomplete patient imaging study.
FDA (openFDA device enforcement)
Reported Dec 1, 2021
Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — The accumulated dose is incorrectly displayed in certain situations. Thisoccurs during an interventional exam using the SmartStep option if the table…
FDA (openFDA device enforcement)
Reported Oct 27, 2021
SIGNA Premier nuclear magnetic resonance imaging system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
9 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 13, 2021
Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — A software anomaly exists in the Centricity Universal Viewer study management feature in which study changes are not propagated to either the…
FDA (openFDA device enforcement)
Reported Oct 6, 2021
AMX Navigate Mobile X-Ray System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — An unexpected column motion while attempting to park the column on the AMX Navigate mobile X-ray system.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 29, 2021
Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — Image acquisition failures and synchronization failure with the Centricity Enterprise Archive
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 8, 2021
Merge Hemo, Software packages 10.2, 10.3, and 10.4
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand — The firm identified a safety issue affecting the software associated with Merge Hemo versions 9.x and 10.x, used in combination with an HL7 lab…
FDA (openFDA device enforcement)
Reported Aug 4, 2021
CARESCAPE PDM-Masimo SpO2. Physiological data monitor.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — Masimo SpO2 Saturation Values can become frozen after an extended length of use without a power down.
FDA (openFDA device enforcement)
Reported Jul 21, 2021
SIGNA Premier - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Reason for recall — GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be…
13 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 14, 2021
Revolution CT
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Reason for recall — GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimator blade does not find its appropriate home position.…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 7, 2021
Revolution EVO, Optima CT660, Optima CT680 CT Systems.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — Improperly loaded software options may result in additional X -ray radiation exposure to the patient.
FDA (openFDA device enforcement)
Reported Jun 30, 2021
Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing ECG…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — If a certain sequence of events occur, the pdf test report that belongs to one patient will appear in a different patient's record when viewed in an…
FDA (openFDA device enforcement)
Reported Jun 23, 2021
GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Innova IGS 6 (GTIN…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details — The IGS system can experience a single vertical line defect where the vertical line divides and horizontally shifts live monitor images into two…
FDA (openFDA device enforcement)
Reported Jun 9, 2021
Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Change Healthcare Canada Company
Matched: Brand · Product · Product details — A software defect was identified where the Image Styles defined by presentation states from CHRS are not displayed in CHEV.
FDA (openFDA device enforcement)
Reported May 19, 2021
NM/CT 850 Nuclear Medicine / CT Scanners
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Reason for recall — GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could cause a shift in CT radiation exposure range of up to 5cm…
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 12, 2021
Centricity Universal Viewer - Product Usage: intended to assist in the viewing, analysis, diagnostic interpretation,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — When the Cross Enterprise Display option is enabled on the Centricity Universal Viewer and Workflow Manager option is used as the PACS worklist…
FDA (openFDA device enforcement)
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