Recall archive
37 recalls · page 2 of 2
Reported Aug 1, 2018
MR Surgical Suite Option Product The MR Surgical Option when integrated with the GE Signa¿ 3.0T or 1.5T magnetic…
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 — There is a potential safety issue with the table transfer release of the MR Surgical Suite System which may cause an unexpected loss of function of…
FDA (openFDA device enforcement)
Reported Aug 23, 2017
Brivo MR355, Optima MR360 Product Usage: The Brivo MR355/Optima MR360 is a whole body magnetic resonance scanner…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
Matched: Brand — Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
8 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 1, 2016
GE Healthcare, Discovery IGS 730. Indicated for use in generating fluoroscopic and rotational images of human anatomy.
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 — Potential non-recoverable loss of image acquisition. The affected Discovery systems may experience multiple X-Ray abort errors before or during a…
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 11, 2016
GE, Revolution CT. The system is intended for head, whole body, cardiac, and vascular X-ray Computed Tomography…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
Matched: Brand · Product · Product details — An out of tolerance torque tool was used on three joints during the manufacturing process. If the X-ray Tube becomes loose on the CT gantry during…
FDA (openFDA device enforcement)
Reported May 4, 2016
GE Healthcare, Aisys and Aisys CS2. Intended to provide general inhalation anesthesia and ventilator support to a wide…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
Matched: Brand · Product · Product details — The vacuum suction tubing could be kinked within the machine resulting in suction less than the 20 lpm required by ISO 10079-3. This could result in…
FDA (openFDA device enforcement)
Reported Apr 20, 2016
GE Healthcare, Aisys CS2 anesthesia..
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 recently become aware of a potential safety issue involving a momentary, self-correcting anesthetic agent bolus when using 21%…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 13, 2016
SIGNA Pioneer MR Systems Product Usage: The SIGNA Pioneer is a whole body magnetic resonance scanner designed to…
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 — Ferrous material in the SIGNA Pioneer Table Control Box (TCB) could cause unexpected attraction to the MR system's high strength magnetic field…
FDA (openFDA device enforcement)
Reported Mar 16, 2016
LightSpeed Ultra (8-slice MDAS), 5120327-3 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is…
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 updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 17, 2016
Mavig Monitor Suspension System, Model GD60, contained in the following Fluoroscopic imaging systems: Advantx LCV+,…
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 recently become aware of a reported incident in which a Mavig suspension arm with monitor assembly fell to the floor.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 27, 2016
GE Healthcare, Aespire 7900, 1009-9012-000 & Aespire View, 1009-9212-000. The family of GE Datex-Ohmeda Aespire…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
Matched: Brand · Product · Product details — The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 23, 2015
GE Healthcare Optima CL323i Product Usage: The angiographic X-ray systems are indicated for use for patients from…
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 recently become aware of a potential safety issue related to a non-recoverable loss of displayed imaging (loss of monitor video)…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 16, 2015
GE Healthcare, Revolution CT Scanners. Revolution CT- The system is intended for head, whole body, cardiac and vascular…
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 recently become aware of a potential issue with routine head scans on your Revolution CT scanner. A potential hazardous situation…
FDA (openFDA device enforcement)
Reported Nov 11, 2015
MR Surgical Suite II Table, Model Number(s): M8074SS, M8053SS, M0074SS. UPDATE 11-4-2015: Model M0001SS
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
Matched: Brand · Reason for recall — GE became aware of an issue with the table transfer release mechanism of the MR Surgical Suite Option. The issue may prevent patient transfer between…
FDA (openFDA device enforcement)
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