Reported Mar 26, 2014 · Terminated
GE Healthcare Optima CT580/Discovery CT590RT scanners running software version 13BW16.3. The Discovery CT 590 RT and…
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- GE Healthcare Optima CT580/Discovery CT590RT scanners running software version 13BW16.3. The Discovery CT 590 RT and Optima CT 580 series of Computed Tomography systems are intended to produce cross-sectional images of the body by computer reconstruction of XRay transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), and Gated (Respiratory and Cardiac) acquisitions in patients of all ages.
- Lot codes and dates
- Mfg Lot or Serial #SE
2,827 of 2,827 codes
PA2314840PA2314841PA2314842PA2314843PA2314844PA2314845A1RF3176GA1RF3638GRA2RF1052GB1RF4038GRB3G44377GB3G44511GB3G44515GB3RF4960GC1RF4686GC1RF4793GC1RF4802GC1RF4827GRD2RF2744GD2RF2778GRD2RF2795GD2RF2796GD2RF2797GD2RF2798GD2RF2799GD2RF2814GD2RF2815GD2RF2816GD2RF2817GD2RF2818GD2RF2819GD2RF2820GD2RF2821GD2RF2822GD2RF2823GD2RF2824GD2RF2825GD2RF2826GD2RF2827GD2RF2828GD2RF2829GD2RF2830GD2RF2831GD2RF2832GD2RF2833GD2RF2834GD2RF2835GD2RF2836GD2RF2837GD2RF2838GD2RF2839GD2RF2840GD2RF2841GD2RF2842GD2RF2843GD2RF2844GD2RF2845GD2RF2846GD2RF2847GD2RF2848G
- Mfg Lot or Serial #
- Amount recalled
- 33 (21 US, 12 OUS)
Where it was sold
Why it was recalled
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 Optima CT580 or Discovery CT590RT scanner. A potential hazardous situation may occur during a CT head scan causing a novel and rare artifact that may hide pathology. When using the head and large head SFOV, which applies the Iterative Bone Option (IBO)
This product could cause temporary or reversible health problems — stop using it.
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