Recall archive
353 recalls · page 12 of 15
Reported Feb 25, 2015
This correction applies to all GE Healthcare MRI systems with superconducting magnets: Discovery MR450, Discovery…
High riskUsing this product could cause serious injury, illness or death — stop using it now.GE Healthcare
Matched: Brand · Product · Product details — 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…
FDA (openFDA device enforcement)
Reported Feb 4, 2015
The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient table, scanner desktop…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare
Matched: Brand — A required quality control test was not performed during installation associated with the software of the Revolution CT scanner.
FDA (openFDA device enforcement)
Reported Jan 21, 2015
GE Healthcare, Proteus XR/a with wall stand model number 600-0301.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare
Matched: Brand · Product · Product details · Reason for recall — 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…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 31, 2014
Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. DICOM devices…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ge Healthcare It
Matched: Brand · Reason for recall — GE Healthcare has become aware of a potential data loss issue associated with empty path names resulting from HL-7 updates when the cache disk is…
FDA (openFDA device enforcement)
Reported Dec 31, 2014
GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes. REF 2059144-001 and 2059144-005. .…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Leonhard Lang GmbH
Matched: Product · Product details — The firm discovered that during the use of these defibrillation electrodes a possibility for arcing and a resulting malfunction exists. This could…
FDA (openFDA device enforcement)
Reported Dec 24, 2014
Innova IGS 540 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — Loss of imaging - affected devices may experience a loss of real-time interventional imaging and/or gantry motion due to the Electromagnetic (EM)…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 19, 2014
GE Healthcare Infinia (including Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye, Infinia II Hawkeye 4,…
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 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…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 19, 2014
OEC¿ UroView 2800. The UroView 2800 is designed to provide fluoroscopic and spot-film imaging of the patient during…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE OEC Medical Systems, Inc.
Matched: Brand · Reason for recall — GE Healthcare initiated a field correction because prior revision of components were potentially installed on certain OEC 9800, FlexiView 8800, OEC…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 5, 2014
Merge Healthcare, Merge Hemo Programmable diagnostic computer. The system comprises the Patient Data Module and the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand · Product · Product details — It has been reported that during use, the SpO2 value displayed on the Hemo Monitor may not update to reflect changes in the patient's oxygen value.…
FDA (openFDA device enforcement)
Reported Oct 22, 2014
eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components of a PACS (Picture Archiving and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand — There is an issue related to eFilm Workstation versions 4.0 and 4.0.1 when having multiple studies open and utilizing the thumbnail panel to select…
FDA (openFDA device enforcement)
Reported Oct 15, 2014
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 to the ECG calculations following a disconnect/reconnect cycle with the Patient…
FDA (openFDA device enforcement)
Reported Oct 8, 2014
GE Healthcare Precision 500D, Classical R&F System. Product Usage: The Precision 500D R&F X-ray System is intended…
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 missing screws used for mounting the overhead Video Monitor to the tray assembly…
FDA (openFDA device enforcement)
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 Jun 4, 2014
The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare
Matched: Brand · Product details — It has been identified that in a reject image workflow where multiple studies are simultaneously opened on the Centricity PACS RA1000 workstation and…
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 14, 2014
Giraffe¿ Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare
Matched: Brand — Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and…
4 more products in this recall
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 Apr 23, 2014
The OEC 9900 Elite mobile fluoroscopy system (image intensified fluoroscopic x-ray) is designed to provide fluoroscopic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE OEC Medical Systems, Inc.
Matched: Brand · Reason for recall — GE Healthcare has identified a potential safety issue related to the screws that attach the workstation monitor spring arm to the extension arm on…
FDA (openFDA device enforcement)
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