Day

October 23, 2013
Company: GE Healthcare, LLC Date of Enforcement Report: 10/23/2013 Class ll: PRODUCT GE, Optima CT660. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data.Recall Number Z-0023-2014 REASON GE Healthcare has recently become aware of a potential safety issue related with the DMPR function and Screen Saved Images on your...
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Company: GE Healthcare, LLC Date of Enforcement Report: 10/23/2013 Class ll: PRODUCT GE PET Discovery 610, PET Discovery 710. Intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging. Recall Number Z-0024-2014 REASON GE Healthcare has recently become aware of a potential safety issue related with the DMPR function and Screen Saved...
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Company: GE Healthcare, LLC Date of Enforcement Report: 10/23/2013 Class l: PRODUCT GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure control ventilation. Recall Number Z-0009-2014 REASON GE Healthcare has recently become aware of a potential safety issue involving the Avance, Avance CS2, and Aisys anesthesia devices. While operating in Pressure...
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