Reported Apr 17, 2013 · Terminated
GE Healthcare, Discovery MR750w 3.0T System. Part Number: 5352293. Product Usage: It is indicated for use as a…
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 MR750w 3.0T System
- Part Number5352293
- Product UsageIt is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra,dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate,blood vessels, and musculoskeletal regions of the body
- Lot codes and dates
- Serial Number
00000000UA002700000000UA001200000000UA002900000000UA003100000000UA003000000000UA002800000000UA003400000000UA003800000000UA004800000000UA004600000000UA005200000000UA004100000000UA0011A00000000UA005500000000UA005600000000UA005700000000UA006400000000UA005300000000UA004400000000UA004700000000UA001000000000UA001300000000UA001700000000UA004200000000UA001600000000UA001900000000UA001500000000UA005800000000UA005100000000UA002500000000UA002400000000UA002000000000UA004000000000UA001800000000UA003600000000UA004300000000UA005400000000UA002200000000UA002300000000UA004500000000UA003900000000UA003500000000UA004900000000UA002100000000UA003300000000UA0037
- Serial Number
- Amount recalled
- 46
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
GE Healthcare has recently become aware of a potential issue due to image flip in frequency encoding direction associated with a specific workflow of your Discovery MR750w system. Image flip issue in frequency encoding direction (including S/I, A/P and R/L) can result in incorrect localization of anatomy and pathological findings.
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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