Reported Nov 18, 2015 · Terminated
GE Healthcare, SIGNA HDx 3.0T. Product Usage: The GE Signa HDx MR system is a whole body magnetic resonance scanner for…
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 HDx 3.0T
- Product UsageThe GE Signa HDx MR system is a whole body magnetic resonance scanner for use as a diagnostic imaging device
- Lot codes and dates
- #N/A
002003-0922-04713441MR51583678732632MR3002003-1015-09713441MR700001009BD6576713792AMR12000000HDMR5656417269MRS100000HDMR10766623433MR100000265552MR09525413TMR00000026005MR8503215MR1002004-1102-177705353TMR00000265805MR2ACB41121MRHDMR5274CBICMR10002005-0606-3615284MR3T000000HDMR5581503216MR3000000HDMR2301269342MR3T000000HDMR3234303340MR00000273869MR8214345SWD3TMR1000000HDMR2559805GI3THDMR2980732223MR00000275049MR5706UGA3T00000275649MR2719595MR00000275647MR63173383T1
#N/A919684MR300000276435MR5901226MR11002BD63EF719542MR00000275050MR3631427MR3T00000276722MR65857853T
N/A143 of 143 codes
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
N/A257 of 257 codes
5204493T000000HDMR5349713524BIMR100000291755MR770389MR3T00000291886MR0703573MR600000291138MR6ALLIANCESIG45200000291747MR4408885MR3T00000291978MR5412692MR100000292486MR8970244MR3T00000292079MR1435688MR300000291979MR3760323MR3T00000296109MR2601268MR3TSGH63105KY214341PDGPMR14602WH9RADNETMR61700000276266MR4817882H3TMR000000HDMR54831063THDX00000281888MR80910273032000000HDMR30010910275006000000HDMR30720910272053000000HDMR5405091027303300000HDMR102910910274020000000HDMR5364110028MR0100000278843MR82644266000000HDMR6091272369400000298101MR7MR13708YR300000265972MR0255894800000280708MR9265543700001001BD631C274428700000HDMR10727416369MR3T00000279069MR9604739MR00000277190MR508242713003300000HDMR10281
243 of 243 codes
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
- Amount recalled
- 350
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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