Recall archive
153 recalls · page 5 of 7
Reported Sep 17, 2014
CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the Airway Gas Option N-CAiO and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product details · Reason for recall — GE Healthcare has recently become aware of a potential safety issue due to a failure of an O2 sensor component associated with the CARESCAPE…
FDA (openFDA device enforcement)
Reported Aug 27, 2014
GE Healthcare, Discovery XR656P/N 5374989/5397837 is intended to generate digital radiographic images of the skull,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details · Reason for recall — GE Healthcare has become aware of a potential safety issue involving the nylon hooks which support the FlashPad" detector on the Discovery XR656 wall…
FDA (openFDA device enforcement)
Reported Jul 30, 2014
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A…
High riskUsing this product could cause serious injury, illness or death — stop using it now.GE Healthcare, LLC
Matched: Brand — Failure of the CO2 detector in Single-width Airway and Extension modules, which may cause a slow continuous decrease of measured Et-/FiCO2 values.…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 9, 2014
GE Healthcare, Proteus XR/a. Proteus XR/a Intended Use: Is intended for use in generating radiographic images of human…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details · Reason for recall — GE Healthcare has become aware of a potential safety issue due to a collimator installation error during a service maintenance activity involving the…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 25, 2014
GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details — Potential loss of airway gas measurement in the Compact Airway Gas Modules. Loosening of the gas sampling pump hex screw in the module pump unit may…
FDA (openFDA device enforcement)
Reported Jun 11, 2014
Kenex Radiation Shield and surgical lamps installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details · Reason for recall — GE Healthcare has recently become aware of a potential safety issue due to the improper installation of a Kenex ceiling suspended radiation shield…
FDA (openFDA device enforcement)
Reported May 28, 2014
GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: The Datex-Ohmeda S/5TM E-NMT module is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details — When the E-NMT-01 module is used in conjunction with the ElectroSensor, the Neuromuscular Transmission (NMT) values may indicate a deeper level of…
FDA (openFDA device enforcement)
Reported May 7, 2014
GE Healthcare, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d) analysis software running on…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details · Reason for recall — GE Healthcare has recently become aware of a potential safety issue due to higher than actual flow values reported on CardiacVX and CardiacVX Flow…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 30, 2014
GE Healthcare, Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w, and Discovery…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details · Reason for recall — Potential safety issue with gradient coil electromechanical connections associated with GE MR Products. Gradient coil electromechanical connections…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 26, 2014
GE Healthcare Optima CT580/Discovery CT590RT scanners running software version 13BW16.3. The Discovery CT 590 RT and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details · Reason for recall — GE Healthcare has recently become aware of a potential safety issue due to a software issue associated with the Head Scan Protocols used on your…
FDA (openFDA device enforcement)
Reported Mar 19, 2014
GE Healthcare, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Innova 2121IQ, Innova 3131IQ;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details · Reason for recall — GE Healthcare has become aware of a potential safety issue involving the innova systems. The Innova system can unexpectedly stop delivering X-rays…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 12, 2014
GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 with the Automatic-View-On-…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details · Reason for recall — GE Healthcare has recently become aware of a potential safety issue with the Solar 8000M/i Patient Monitor Automatic-View-On-Alarm (AVOA) feature.…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 5, 2014
GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-alone Infant Resuscitation System. Product…
High riskUsing this product could cause serious injury, illness or death — stop using it now.GE Healthcare, LLC
Matched: Brand · Product · Product details — Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 26, 2014
GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery 690. The GE Discovery XR and XA Systems…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details · Reason for recall — GE Healthcare has recently become aware of a potential safety issue due to scatter overcorrection associated with the List Mode Replay feature of…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 12, 2014
GE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging systems. The Precision 500D R&F X-ray System…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details · Reason for recall — GE Healthcare has recently become aware of a potential safety issue involving the Precision 500D, Precision MPI & Precision RXI X-ray imaging systems…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 5, 2014
GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems. Intended to produce cross-sectional images of the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details — There is an issue with the Manual Film Composer feature on some CT products. There is an opportunity, while following a specific workflow, to create…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 29, 2014
Video Monitor Suspensions that may be on the following Fluoroscopic and Radiographic X-Ray systems: Precision 500D,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Reason for recall — Missing screws in the overhead Video Monitor Suspension. GE discovered that the 4 outer screws that hold the overhead Video Monitor Suspension to the…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2014
GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiographic Systems. Model numbers 5555000-5,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details — There exists a software issue associated with patient selection from the worklist on the Optima XR200 with Digital Upgrade, and Optima XR220amx…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 15, 2014
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details · Reason for recall — GE Healthcare has recently become aware of a potential safety issue which affects all Patient Date Modules produced from April 2007 through June…
FDA (openFDA device enforcement)
Reported Dec 25, 2013
Multi Absorber Original, Disposable M1173310 Multi Absorber Original, Disposable, package of 6 pcs, GE Healthcare…
High riskUsing this product could cause serious injury, illness or death — stop using it now.GE Healthcare, LLC
Matched: Brand · Product · Product details · Reason for recall — GE Healthcare has recently become aware of a potential safety issue due to air leakage associated with the CO2 Multi Absorber.
FDA (openFDA device enforcement)
Reported Dec 18, 2013
HGE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40, and Monitor B40 K122253 (Procare Monitor…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details · Reason for recall — GE Healthcare has recently become aware of a potential safety issue due to ECG filter settings associated with the B20/B40 V1, B30 and B40 V2 Patient…
FDA (openFDA device enforcement)
Reported Nov 27, 2013
GE Healthcare Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615. The GE Discovery NMJCT 670 system…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details · Reason for recall — GE Healthcare has recently become aware of a potential safety issue related to a SPECT scan procedure used for pulmonary imaging. Contact between the…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 20, 2013
AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION), AW Server.…
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 a potential safety issue due to the image orientation within GSI viewer on AW products. The GSI Viewer…
FDA (openFDA device enforcement)
Reported Oct 23, 2013
GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure control ventilation.
High riskUsing this product could cause serious injury, illness or death — stop using it now.GE Healthcare, LLC
Matched: Brand · Product · Product details · Reason for recall — GE Healthcare has recently become aware of a potential safety issue involving the Avance, Avance CS2, and Aisys anesthesia devices. While operating…
5 more products in this recall
FDA (openFDA device enforcement)
RecallNow is not a government agency. Every notice above is published by the FDA, USDA FSIS, or CPSC and links back to its source. Back to the look-up