Reported Feb 22, 2017 · Terminated
Discovery MR450 The systems are whole body magnetic resonance scanners designed to support high resolution, high…
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?
- Discovery MR450 The systems are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio, and short scan times. It 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
- Mfg. Lot or Serial # System IDNot Available
00001106XF509E209225VC45000001106XF50A6858939MR4000000000R7216858939MR3000000000R2645202715MR200000842BD50C2202476MR1000000000R7025217383CMR500000944BD6155MR129036101BD66B6573884MRI00000945BD6182417COXMR1000000000R2768HSSFMR45000001009BD65C1HSS75MR45000000944BD6166803434MRI00000298722MR0803434MR200000300039MR5832522MR2
Not Available713566SMITH11106xf508e713566SMITH300000296429MR4281364MR200000833BD4AE7920830MR45000000933BD5DF8304256MR200000294451MR0030020MR03000000000R7320403541MR100000944BD616B403955MR1000000000R7149250727MR2
73 of 73 codes
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
- Mfg. Lot or Serial # System ID
- Amount recalled
- 60
Where it was sold
Why it was recalled
Potential safety issue with the patient bore heating on the Discovery MR450 narrow bore 1.5T MRI. In the event of a RF component failure, typically happening after extended system use, a small area on the bore surface may become warmer than normal. If this happens in an area where there is patient contact with the bore, and proper padding is not used, it may cause a serious burn.
This product could cause temporary or reversible health problems — stop using it.
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