Reported Nov 18, 2015 · Terminated
GE Healthcare, SIGNA HDxt 3.0T. Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body…
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 HDxt 3.0T
- Product UsageThe 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner for use as a diagnostic imaging device
- Lot codes and dates
- #N/A
92 of 92 codes
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
N/A269342MR3TCH200000285497MR4517374MR3T002004-0416-18415353UMR9002005-0316-09850656TD3T00000282373MR0408GS3TMR000000HDMR55695853413T00000300458MR7RADNETMR59400000287256MR2305674MR1000000HDMR6028865218MR3T000000HDMR42306109883TMR00000276721MR8407BDIMR00000290478MR73017233TMR00002982315MR9ALLIANCESIG46800000939BD5F59310623MR00000280229MR6INSIGHTMR323300000296233MR0515282MR100000280671MR9RADNETMR1583000000HDMR6392602588CMR100000297726MR2RADNETMR1589
N/A218 of 218 codes
407SMWPMR100001011BD6684480464MR100000298718MR8RADNETMR15950002005-1109-6225763MR00000299962MR1RADNETMR59000000300457MR9RADNETMR159700000300769MR7RADNETMR59200000298773MR3213387MR35A14718B626359MR3000000HDMR3359213777MR00000265629MR6405CDIMR000000HDMR2303269342MR3T200000283743MR3808AMIMR00000848BD531FRADNETMR612000000HDMR3154RADNETMR165900000275474MR5RADNETMR615CG10410053631686MR3T00001302FMM01K661AIMR200000282794MR7812450MR300000910BD57EDRADNETMR62000001011BD668816683THDX00000270465MR82901847MR3T000000HDMR6209422SIGNA3T00000000WB0607AZ4013MR0100000290310MR2030022MR0100001009BD6557BA4080MR0100000286065MR8270616400001012BD6695288541700000008327YR92871974-100000299495MR2MRWB054000000308026MR4
No Serial08302704100201000001012BD66E008302700014311000001007BD646708302700649551100000300459MR508302702422011100001011BD661A08302760582631100000260694MR508302700273081100000271248MR7083027001106411CG10410025083027105227014
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
- Amount recalled
- 215
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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