Reported Nov 18, 2015 · Terminated
GE Healthcare, SIGNA HD 3.0T. Product Usage: The Signa Profile EXCITE MR system is an open, whole body scanner for use…
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 HD 3.0T
- Product UsageThe Signa Profile EXCITE MR system is an open, whole body scanner for use as a diagnostic imaging device. It may be utilized for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR safe biopsy needles
- Lot codes and dates
- #N/A TRAINING789 N/A
88 of 88 codes
002005-1018-15352333MR3T000006-0523-13716859MR3T00001003BD6425352376MR3T200000280001MR9MR12903100000285499MR02154563TMR000000HDMR3702RADNETMR55400000274930MR7805CHLIMR100000280057MR1513558MR3T00000274998MR4213977MR2002004-0713-06ACB41109MR002004-0406-08323442MR2002004-0406-15323442MR100000273396MR27326133T002004-1115-19865373MR1002005-0316-057576713T0002005-0606-4205750MR200000274839MR09287573TMR002006-0119-15559325CIIMR10002005-1201-3256734MR3T002005-1003-15201487MR000000HDMR29966053223TMR000000HDMR3245775RDC3T002005-0620-16405634S3T00000269460MR2602406IMR00000275670MR8813972VAMR0002005-1121-7480614MR100000273230MR3602689MR1002005-1201-20601288MR3T00000275936MR3ALLIANCESIG46300000275086MR7650306SMR3T
290392MR0¿¿¿¿¿¿¿¿¿¿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
N/A08242727001700000265589MR2DK1083MR0400000000WB0692ET1009MR0100000262460MR90828270021IB0100000270245MR4082827002300000272433MR4083027002101706
08302720210139600000275668MR2IR1503MR0100000279077MR2KW1004MR0300000262791MR756MRE3TH256537000000280669MR3092027902500000309597MR3NO1011MR0100000272533MR1787840CIRT3T00000276591MR5787653MR3T00000279460MR0787740MR3T00000275845MR6RU1283MR0100001002BD637FMEX6890000000HDMR10201GP17832800000275642MR7GEE34040000000000WB658MPX1000000000266820MR0387040MR0600000262456MR734208MRS0100000271120MR834006MRS0300000266270MR810146MRS0300000274693MR13882630908MRMET
- Amount recalled
- 97
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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