GE Healthcare Recalls
567 recalls on record · June 27, 2012 to April 8, 2026 · Medical Devices
Recalls by year
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 6, 2015Medical DevicesFDA
GE Healthcare recalls GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR220 amx
Hazard: An issue was identified with the mAs accuracy check performed on the system that could result in inaccuracies in the 10% to 20% range for exposure times longer than 15 msec.
May 6, 2015Medical DevicesFDA
GE Healthcare recalls GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR200 amx
Hazard: An issue was identified with the mAs accuracy check performed on the system that could result in inaccuracies in the 10% to 20% range for exposure times longer than 15 msec.
May 6, 2015Medical DevicesFDA
GE Healthcare recalls GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx
Hazard: An issue was identified with the mAs accuracy check performed on the system that could result in inaccuracies in the 10% to 20% range for exposure times longer than 15 msec.
April 22, 2015Medical DevicesFDA
GE Healthcare recalls Kenex Radiation Shield installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems.
Hazard: GE Healthcare has recently become aware of an improper installation of a ceiling suspended pendent supporting a radiation shield and/or surgical lamp. The pendent system was not installed per specified installation requirements. There has been a reported incident of a radiation shield falling from the ceiling causing a minor injury.
April 8, 2015Medical DevicesFDA
GE Healthcare recalls GE Healthcare, Aespire 7900, Aespire View Anesthesia Machines. Model numbers 1009-9012-000. Intended to provide gene
Hazard: Specific Aespire 7900 Anesthesia Machines have an increased likelihood of failure of the CPU circuit board. This could result in a blank display or loss of mechanical ventilation.
April 1, 2015Medical DevicesFDA
GE Healthcare recalls GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T WITH EXCITE,
Hazard: GE Healthcare has become aware of a potential safety issue involving MRI systems due to software versions not being maintained properly at some sites.
March 25, 2015Medical DevicesFDA
GE Healthcare recalls GE Healthcare, Treadmill T2100 and Treadmill T2000 with power cord part numbers 408930-001 Rev E, 408930-002 Rev C, or 2
Hazard: Potential safety issue due to improper assembly associated with the power cords of T2100 and T2000 Treadmills.
March 25, 2015Medical DevicesFDA
GE Healthcare recalls GE Healthcare Millennium VG, Discovery VH and VariCam Nuclear Medicine systems, all configurations. Product Usage: T
Hazard: GE Healthcare has recently become aware of a potential safety issue due to a collimator falling off a VG system during a Quality Control check, while the detectors were rotating. No injuries have been reported to date
March 25, 2015Medical DevicesFDA
GE Healthcare recalls GE Healthcare Engstrom Carestation, Engstrom Pro, Cart Only S/5 EC. GE model numbers 1505-8538-000, 1505-9000-000, and 1
Hazard: Potential failure of the caster mounting hardware, which may result in the ventilator falling/tipping (overbalancing).
March 18, 2015Medical DevicesFDA
GE Healthcare recalls GE Healthcare Proteus XR/a with wall stand model number 2260354. Intended for use in generating radiographic images o
Hazard: Potential breakage of the steel cable which supports the bucky device in certain wall stands of Proteus XR/a X-ray imaging systems. A fall of a bucky while the system is in use could result in an injury to a patient or operator.
March 4, 2015Medical DevicesFDA
GE Healthcare recalls The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by t
Hazard: Using Merge Exam in single Study Mode may result in Missing Study Record (Cannot Display Exam, Send Exam, etc). Exam merge in Single Study Mode may fail on &amp
February 25, 2015Medical DevicesFDA
GE Healthcare recalls This correction applies to all GE Healthcare MRI systems with superconducting magnets: Discovery MR450, Discovery MR750,
Hazard: At certain sites, the MRU may not be connected to the magnet. In emergency situations, a disconnected MRU could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injuries. The MRU must be connected to the magnet at all times.
February 4, 2015Medical DevicesFDA
GE Healthcare recalls The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient table, scanner desktop
Hazard: A required quality control test was not performed during installation associated with the software of the Revolution CT scanner.
January 21, 2015Medical DevicesFDA
GE Healthcare recalls GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner.
Hazard: Potential safety issue due to a required torque check on three bolted joints of the Revolution CT scanner. No injuries or illnesses reported.
January 21, 2015Medical DevicesFDA
GE Healthcare recalls GE Healthcare, Discovery IGS 730 & Discovery IGS 740. Discovery IGS 730 : The angiographic X-ray systems are indicate
Hazard: Potential unintentional system motion or rotation due to a positioning user interface issue with Discovery IGS 730 and 740 products.
January 21, 2015Medical DevicesFDA
GE Healthcare recalls GE Healthcare, Proteus XR/a with wall stand model number 600-0301.
Hazard: GE Healthcare has recently become aware of a potential safety issue involving the breakage of the two steel cables which support the bucky device in the wall stand of Proteus XR/a X-ray imaging systems. No injuries reported.
December 24, 2014Medical DevicesFDA
GE Healthcare, LLC recalls Innova 4100IQ Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnost
Hazard: Loss of imaging - affected devices may experience a loss of real-time interventional imaging and/or gantry motion due to the Electromagnetic (EM) sensitivity of the grid detection mechanism.
December 24, 2014Medical DevicesFDA
GE Healthcare, LLC recalls Discovery IGS 740 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational
Hazard: Loss of imaging - affected devices may experience a loss of real-time interventional imaging and/or gantry motion due to the Electromagnetic (EM) sensitivity of the grid detection mechanism.
December 24, 2014Medical DevicesFDA
GE Healthcare, LLC recalls Innova IGS 540 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational ima
Hazard: Loss of imaging - affected devices may experience a loss of real-time interventional imaging and/or gantry motion due to the Electromagnetic (EM) sensitivity of the grid detection mechanism.
November 19, 2014Medical DevicesFDA
GE Healthcare, LLC recalls Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system. Models H3100TP, H3100TN, H3100TT, H31
Hazard: GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems.
November 19, 2014Medical DevicesFDA
GE Healthcare, LLC recalls Optima NM/CT 640, Models H3100YA, H3100YC. Product Usage: The GE Optima NM/CT 640 system is intended for General N
Hazard: GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems.
November 19, 2014Medical DevicesFDA
GE Healthcare, LLC recalls Discovery NM 630, dual detector free-geometry integrated nuclear imaging system. Models H3100RC, H3100RD, H2401LW.
Hazard: GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems. This check is being added to prevent a portion of the system falling onto the patient during a scan due to fasteners being loose that secure the camera to the gantry.
November 19, 2014Medical DevicesFDA
GE Healthcare, LLC recalls Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Models H3100NA, H3100PP, H3100RA, H2
Hazard: GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems.
November 19, 2014Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare Varicam/VG and VG Hawkeye devices. Models H3000YA, H3000YB, H3000YC, H3000YD, H2508PA, H2508PB, H2508PC,
Hazard: GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems.
November 19, 2014Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare Infinia (including Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye, Infinia II Hawkeye 4, Infinia
Hazard: GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems.
October 15, 2014Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare Carescape Patient Data Module
Hazard: GE Healthcare has recently become aware of a potential safety issue to the ECG calculations following a disconnect/reconnect cycle with the Patient Data Module, when used with the Carescape Bx50 monitors. If the PDM is quickly disconnected and reconnected (a less than 10 second cycle) from a Carescape Bx50 monitor following a Patient Discharge or during active monitoring, the ECG waveform an
October 8, 2014Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare Precision 500D, Classical R&F System. Product Usage: The Precision 500D R&F X-ray System is intend
Hazard: GE Healthcare has become aware of a potential safety issue involving missing screws used for mounting the overhead Video Monitor to the tray assembly on a single monitor suspension. This issue affects the Precision 500D X-ray imaging systems.
September 17, 2014Medical DevicesFDA
GE Healthcare, LLC recalls CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the Airway Gas Option N-CAiO and re
Hazard: GE Healthcare has recently become aware of a potential safety issue due to a failure of an O2 sensor component associated with the CARESCAPE respiratory modules, the Airway Gas Option and their respective service exchange units.
August 27, 2014Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare, Discovery XR656P/N 5374989/5397837 is intended to generate digital radiographic images of the skull, spin
Hazard: GE Healthcare has become aware of a potential safety issue involving the nylon hooks which support the FlashPad" detector on the Discovery XR656 wall stand systems. There have been reported incidents of detector falls, but no injuries have been reported.
July 30, 2014Medical DevicesFDA
GE Healthcare, LLC recalls GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in multiple areas and intrahos
Hazard: Possible sound loss associated with the CARESCAPE Monitor B650. When an external display is connected to the CARESCAPE Monitor B650 using a USB extender cable with an active USB hub, the system may experience a sound loss including alarm sounds from the patient monitor. This may occur if the external display is powered off and on during normal operation of the monitor.