Recall archive
353 recalls · page 15 of 15
Reported Feb 6, 2013
AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version 7.5, 5160092-4 version 7.6.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Reason for recall — It was reported by a customer site that when using GE AdvantageSim MD on Advantage Workstation, the series could be incorrectly labeled in image view…
FDA (openFDA device enforcement)
Reported Jan 2, 2013
GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Circuit Kit Disposable with Size…
High riskUsing this product could cause serious injury, illness or death — stop using it now.GE Healthcare, LLC
Matched: Brand · Product · Product details — Disposable T-Piece circuits used with resuscitation systems are unable to achieve maximum Peak Inspiratory Pressure (PIP) during the pre-use check…
FDA (openFDA device enforcement)
Reported Dec 26, 2012
GE Healthcare, Dash 3000/4000/5000. The Dash 3000/4000/5000 patient monitor is intended for use under the direct…
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 issue due to an unexpected loss of Custom Automatic NBP Measurement cycling associated with…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 5, 2012
GE Healthcare Optima XR 220amx 30kw Mobile X-ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx,…
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 software issue on the interface of the mobile radiographic product, Optima XR22Oamx and Optima XR200amx with…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 28, 2012
GE Healthcare Optima XR 200amx with digital upgrade Mobile general purpose radiographic imaging of the human head 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 — It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 28, 2012
Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 A fetal scalp circular (spiral) electrode and applicator…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Vital Signs Devices, a GE Healthcare Company
Matched: Brand — Thirty fetal scalp electrodes were found to have an incomplete package seal and lacked the printed lot number stamped on during sealing.
FDA (openFDA device enforcement)
Reported Oct 31, 2012
GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1 Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage…
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 an issue associated with the magnification images acquired on non-GE digital mammography systems and your Seno…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 19, 2012
Optima XR220amx Mobile general purpose radiographic imaging of the human head and body.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects and clears an additionally displayed screen the…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 5, 2012
OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); IT3500 Plus (InstaTrak Plus); ConneCTstat;…
High riskUsing this product could cause serious injury, illness or death — stop using it now.GE OEC Medical Systems, Inc.
Matched: Brand · Reason for recall — GE Healthcare Surgery had discovered that using the Inverted Headset Placement is not a validated configuration with the IT 3000, 2500, 2500 plus,…
FDA (openFDA device enforcement)
Reported Aug 29, 2012
GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City, UT. Mobile fluoroscopic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE OEC Medical Systems, Inc.
Matched: Brand · Product · Product details — X-ray units did not meet manufacturer's specification for linearity.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 22, 2012
GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volume Viewer 2 (version 6.4-6.8)…
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 is informing you of incorrect measurements when using the Aorta analysis protocol or customized protocols. Until a new software version…
FDA (openFDA device enforcement)
Reported Jul 25, 2012
GE Healthcare Optima Mobile X-ray System. The GE Automatic Mobile X-Ray (AMX ) Series are intended to take exposures…
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 software issue on the interface of the mobile radiographic product, Optima XR200amx, ond Optima XR220amx related…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 18, 2012
GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software.…
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 incorrect alignment of fused CT and PET images associated with the CT/PET fusion…
FDA (openFDA device enforcement)
Reported Jul 18, 2012
InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Number IT3500 Plus. Product…
High riskUsing this product could cause serious injury, illness or death — stop using it now.GE OEC Medical Systems, Inc.
Matched: Brand · Reason for recall — Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 18, 2012
enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Vital Signs Devices, a GE Healthcare Company
Matched: Brand · Product details — The EnFlow Warmer Strap does not meet the requirements of the biocompatibility standard (ISO 10993) for products that may have contact with skin for…
FDA (openFDA device enforcement)
Reported Jun 27, 2012
GE Healthcare, Aestiva/5 7900 SmartVent, anesthesia machine. Used in Datex-Ohmeda Aestiva/5 Anesthesia Systems.
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 the interlock slide mechanism missing from the 3-vaporizer manifold of…
FDA (openFDA device enforcement)
Reported Jun 20, 2012
GE Healthcare Revolution XR/d; GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188 Model numbers: 2259988-2 &…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.General Electric Med Systems LLC
Matched: Product · Product details — An incident was reported that an operator's finger was pinched between the fixed roller and the gliding tabletop of a Proteus XR/a Table while moving…
2 more products in this recall
FDA (openFDA device enforcement)
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