Reported May 8, 2013 · Terminated
GE Healthcare, GE 1.5T SIGNA HDe MR SYSTEM. Indicated for use as a diagnostic imaging device.
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, GE 1.5T SIGNA HDe MR SYSTEM. Indicated for use as a diagnostic imaging device.
- Lot codes and dates
- Mfg Lot or Serial #
822 of 822 codes
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
- Mfg Lot or Serial #
- Amount recalled
- 822 (154 US; 668 OUS)
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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