Reported Nov 18, 2015 · Terminated
GE Healthcare, Discovery MR750w 3.0T. Product Usage: The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w…
GE Healthcare
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 · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- GE Healthcare, Discovery MR750w 3.0T
- Product UsageThe Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T Systems are whole body magnetic resonance scanners for diagnostic imaging
- Lot codes and dates
- N/A 858657HDMR3 00000310141MR7 AM12O59187 N/A
266 of 266 codes
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
N/A686 of 686 codes
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
N/A210AMVAMRUA0326614293MR900000310301MR7904483MR3T00000309694MR8415UCBHMR31406NMM0C5412914MR00000000UA0331703573MR1DVUA0224503251PMR30000000UA0315A516NS7113T
N/A865984MR750UA0319920738MR75000000309905MR8RADNETMR62100000000UA0355716740MR1UA0368MR22905000000000UA0388318443MR200000000UA0342303837MR2
N/A817433HSWMR2UA0374248533750W00000000UA0203225763MR200000000UA0139847872ZMR200000000UA0405937208MR100000000UA0367336832MR750309219MR4734845VA750MR309815MR94191835
00000000UA0443_DUP9157473TMR00000000UA0309970624MR100000000UA0363MSK53MR0200000000UA0402480342MR300000000UA0421608265MR750W00000000UA0436608VAMR750W
No Serial143 of 143 codes
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
312 of 312 codes
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
- Amount recalled
- 756
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling suggests the actual SAR in the head could exceed IEC60601-2-33 limit of 3.2 W/kg for some scans.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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