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Recall archive

94,355 stored notices, from Jun 20, 2012 to Sep 23, 2026.

153 recalls · page 7 of 7

Medical devices

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 recallGE 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)

Medical devices

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 recallGE 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)

Medical devices

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 recallIt 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)

Medical devices

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 recallGE 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)

Medical devices

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: BrandSoftware 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)

Medical devices

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 recallGE 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)

Medical devices

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 recallGE 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)

Medical devices

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 recallGE 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)

Medical devices

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 recallGE 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)

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