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GE Medical Systems Recalls
168 recalls on record · November 11, 2015 to July 22, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 16, 2016Medical DevicesFDA
GE Medical Systems, LLC recalls LightSpeed 16 (MDAS only , , 2339985 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indica
Hazard: GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value.
March 16, 2016Medical DevicesFDA
GE Medical Systems, LLC recalls Discovery ST, , 2339985 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head a
Hazard: GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value.
March 16, 2016Medical DevicesFDA
GE Medical Systems, LLC recalls Discovery LS, 2286327 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head a
Hazard: GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value.
March 16, 2016Medical DevicesFDA
GE Medical Systems, LLC recalls LightSpeed Ultra (8-slice MDAS), 5120327-3 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is
Hazard: GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value.
February 17, 2016Medical DevicesFDA
GE Medical Systems, LLC recalls GE Healthcare, Optima XR200amx, Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographi
Hazard: Potential safety latch mechanism failure. The safety latch, within the column that supports the horizontal arm, is a backup in the unlikely event the primary safety cable breaks. A fall of the arm assembly could result in bodily harm to a person.
February 17, 2016Medical DevicesFDA
GE Medical Systems, LLC recalls GE Healthcare, Brivo XR285amx Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic i
Hazard: Potential safety latch mechanism failure. The safety latch, within the column that supports the horizontal arm, is a backup in the unlikely event the primary safety cable breaks. A fall of the arm assembly could result in bodily harm to a person.
February 17, 2016Medical DevicesFDA
GE Medical Systems, LLC recalls GE Healthcare, Optima XR220amx, Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographi
Hazard: Potential safety latch mechanism failure. The safety latch, within the column that supports the horizontal arm, is a backup in the unlikely event the primary safety cable breaks. A fall of the arm assembly could result in bodily harm to a person.
February 17, 2016Medical DevicesFDA
GE Medical Systems, LLC recalls Mavig Monitor Suspension System, Model GD60, contained in the following Fluoroscopic imaging systems: Advantx LCV+, Adv
Hazard: GE Healthcare has recently become aware of a reported incident in which a Mavig suspension arm with monitor assembly fell to the floor.
January 27, 2016Medical DevicesFDA
GE Medical Systems, LLC recalls Anesthesia device service kits. ASSY-MSN, VENT ENGINE ASSY, 1503-8101-000 ASSY-MSN, VENT ENGINE ASSY 7900, 1009-82
Hazard: 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 mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.
January 27, 2016Medical DevicesFDA
GE Medical Systems, LLC recalls GE Healthcare, Aisys CS2,1011-9050-000; Avance Amingo,1009-9002-000, & Avance CS2, 1009-9050-000. The GE Datex-Ohmeda
Hazard: 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 mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.
January 27, 2016Medical DevicesFDA
GE Medical Systems, LLC recalls GE Healthcare, Aisys, 1011-9000-000. The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhal
Hazard: 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 mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.
January 27, 2016Medical DevicesFDA
GE Medical Systems, LLC recalls GE Healthcare, Aestiva MRI, 1006-9310-000. This version of the Datex-Ohmeda 7900 ventilator is used in Datex-Ohmeda Aes
Hazard: 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 mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.
January 27, 2016Medical DevicesFDA
GE Medical Systems, LLC recalls GE Healthcare, Aestiva 7900, 1006-9305-000. This version of the Datex-Ohmeda 7900 ventilator is used in Datex-Ohmeda Ae
Hazard: 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 mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.
January 27, 2016Medical DevicesFDA
GE Medical Systems, LLC recalls GE Healthcare, Aespire 7900, 1009-9012-000 & Aespire View, 1009-9212-000. The family of GE Datex-Ohmeda Aespire anest
Hazard: 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 mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive or prolonged pressure in the patient breathing circuit during ventilation potentially resulting in barotrauma.
December 23, 2015Medical DevicesFDA
GE Medical Systems, LLC recalls GE Healthcare Optima IGS 320. Product Usage: The angiographic X-ray systems are indicated for use for patients from
Hazard: GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable loss of displayed imaging (loss of monitor video) involving Optima CL323i & Optima IGS 320 systems.
December 23, 2015Medical DevicesFDA
GE Medical Systems, LLC recalls GE Healthcare Optima CL323i Product Usage: The angiographic X-ray systems are indicated for use for patients from n
Hazard: GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable loss of displayed imaging (loss of monitor video) involving Optima CL323i & Optima IGS 320 systems .
December 16, 2015Medical DevicesFDA
GE Medical Systems, LLC recalls GE Healthcare, Revolution CT Scanners. Revolution CT- The system is intended for head, whole body, cardiac and vasc
Hazard: GE Healthcare has recently become aware of a potential issue with routine head scans on your Revolution CT scanner. A potential hazardous situation can occur during a routine head scan with possible artifacts that may emulate pathology between the brain tissue and bone in the head images. No injuries have been reported to date related to this issue.
November 11, 2015Medical DevicesFDA
GE Medical Systems, LLC recalls MR Surgical Suite II Table, Model Number(s): M8074SS, M8053SS, M0074SS. UPDATE 11-4-2015: Model M0001SS
Hazard: 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 the MR and surgical tables.