Reported Nov 18, 2015 · Terminated
GE Healthcare, SIGNA Excite 3.0T. MR System for use as a diagnostic imaging device.
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, SIGNA Excite 3.0T. MR System for use as a diagnostic imaging device.
- Lot codes and dates
110 of 110 codes
00000304469MR0910609CF3T00000000043586336713WFUMR002004-0924-11321MR3T32333901726OPMR002004-0520-05727785MR00000005232YR4414649MR5000000HDMR2722858657MR115560449085223T002004-0520-06407999MR3T002004-0805-018109873T00000263655MR3321MR3T200000006583YR9HSS3T5002005-0216-15731425MR2002005-0216-196053883T002005-1020-30248465MR3T002005-0127-12248849MR3T002004-1117-11916UCDMR3T000000HDMR37372059393T002005-0331-11919684MR6000000HDMR3654402219MR3T002005-0519-19205345MR3T000000000R3780210921SWGMR002005-1201-36662MSU3T000000HDMR5675407303MR3T00000267527MR0903870VM3TMR1000000HDMR5786602285MR400000HDMR10672ASLWEST30MR00000269041MR0091027204400000266160MR1255000000000257756MR7082427230015
- Amount recalled
- 55
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.
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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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