Reported May 8, 2013 · Terminated
GE Healthcare, Discovery MR750, Discovery 450, Optima 450W (with and without GEM), Signa HDx, Signa HDxt, Signa HDi,…
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, Discovery MR750, Discovery 450, Optima 450W (with and without GEM), Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant. Indicated for use as a diagnostic imaging device.
- Lot codes and dates
- Mfg Lot or Serial #0 1
239 of 239 codes
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
00000008993YR*1,442 of 1,442 codes
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
00357 of 357 codes
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
- Mfg Lot or Serial #
- Amount recalled
- 4338
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Products. The axial and coronal reformatted images from a sagittal 3D series (such as with applications of FSPGR-3D T1, BRAVO T1, or CUBE T1) of over 126 slices may display a left-to-right image flip . In addition, the acquired sagittal images may be annotated with left-right location annotation revers
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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