Reported May 8, 2013 · Terminated
GE Healthcare, Optima MR360/Brivo MR355 (HDsv), GE 0.35T Signa Ovation HD MR System, GE 0.2T Signa Profile HD MR…
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 MR360/Brivo MR355 (HDsv), GE 0.35T Signa Ovation HD MR System, GE 0.2T Signa Profile HD MR System. Indicated for use as a diagnostic imaging device.
- Lot codes and dates
- Mfg Lot or Serial #
864 of 864 codes
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
- Mfg Lot or Serial #
- Amount recalled
- 864 (57 US; 802 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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