Reported Oct 2, 2013 · Terminated
GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the following model numbers: 2395001, 2395001-2,…
GE Healthcare, LLC
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, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
GE 1.5T Signa HDxt3.0T Signa HDxtSigna VibrantHD23 Software
- and the following model numbers2395001, 2395001-2, 2395001-3, 2395001-4, 5269997-2, 5269997-4, 2377062-61, 5127452-3, 5127452, 5337894-3, 5337894-4, 5911000-4, 5911000-5, 53085735308573-2. GE Discovery MR750w 3.0T, Discovery MR750 3.0T, Optima MR450w 1.5T, Discovery MR450 1.5T. The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. IT is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including but not limited to head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used
- Lot codes and dates
- REF 60850 Mfg Lot or Serial #Not Available 00000237000MR5 00000226580MR9 00000230105MR9 00000285956MR9 00000305386MR5 00000012562YR5 Not Available 000002UA4907WH 00002UA2400LWZ 00000177845MR5 00000165805MR3 00000836BD4DE2 00000012383YR6 00000269416MR4 Not Available
00000204882MR500000233303MR700000241103MR100000245171MR400000247204MR100000173038MR100000136104MR700000264553MR900000265096MR800000005532YR700000007097YR900000007556YR400000281841MR700000289583MR70000SGH919066P00000013883YR40000SGH231PPQK00002UA2050JKX00002UA2400LWP00002UA24315PT00002UA24315PY00002UA24315P500002UA24907W700000266797MRO00000267189MR000000270550MR700000283466MR100000305180MR200000306054MR80000267533MR8A
Not Available68 of 68 codes
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
Not Available 00001140FMM0FU Not Available Not Available Not Available Not Available Not Available 00002UA211170H 00000304248MR8 00000304750MR3 Not Available 00000PH150435A 00000016399M68 00000016658M67 Not Available153 of 153 codes
00000304307MR200000013981YR600002UA2400LX200000213294MR280981100000273256MR800000221025MR000000174670MR000000259576MR700000288072MR200000298886MR300000304463MR300000002761M6500000002763M6100000002766M6400000003066M6800000012720M6900000012955M6100001001BD631C00001002BD637900001011BD664100001012BD66F700000PH150014A00000PH150319A00000PH150329A00000PH150377A00000283431MR500000284207MR800002UA9300HNM00000012016YR200000013024YR500000013230YR800000013605YR100000013791YR900000013884YR200000014042YR600000014077YR200000015592YR900000016030YR900000292983MR400000296037MR500000296108MR400000298410MR200000298933MR300000299274MR100000299666MR800001018XF503300001018XF503500001027XF500800001037XF507E00001037XF507800001042XF502A00001042XF503B00001043XF500A00001043XF500C00001043XF500D00001043XF501100001046XF500C00001046XF5016
Not Available Not Available 00000275465MR3 00000287379MR2 00000005432M60 00001043XF5019 00000PH150400A Not Available Not Available Not Available Not Available00002UA2321LKJ00002UA4200LX100000241131MR200000261940MR100000007028M6400002UA2050JKQ00002UA22827QB00002UA24907WF00000269348MR900000200399MR400000012253YR100002UA22827QX00002UA2400LWL00000301918MR900000015792YR500001051XF5032
FMI 60842 Mfg Lot or Serial #00000013042YR700000272099MR300000283433MR100001052XF50210000SGH212RCRC00002UA22827QJ00000013142YR500002UA22912Y400000286730MR700000290035MR500002UA22827QS00002UA22827QV00000265845MR800000266189MR000000303354MR500000277200MR200002UA2050JKL00000298690MR90000SGH136SZ1700002UA21117OB00000304774MR300000PH150389A
2624 of 624 codes
00000000UA001200000000UA002600000000UA002700000000UA002800000000UA002900000000UA003000000000UA003100000000UA003400000000UA003800000000UA004100000000UA004600000000UA004800000000UA005000000000UA005200000000UA005300000000UA005500000000UA005600000000UA005700000000UA006000000000UA006400000000UA006500000000UA006600000000UA006800000000UA006900000000UA007100000000UA007300000000UA007400000000UA007500000000UA008300000000UA008500000000UA008600000000UA008900000000UA009100000000UA009200000000UA009600000000UA009900000000UA011500000000UA011600000000UA011700000000UA012400000000UA012800000000UA01380000000UA0001A0000000UA0011A0000000UA0032A00000029854MR500000030154MR000000030251MR200000123FMM0K400000288408MR800000288907MR900000289309MR700000289310MR500000289961MR500000290050MR400000290137MR900000290202MR100000290457MR100000290502MR400000290636MR0
1871 of 71 codes
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
217 of 217 codes
00000000UA001600000000UA001900000000UA007000000000UA007200000000UA007700000000UA010500000120FMM0VC00000290985MR100000292844MR800000292928MR900000293042MR800000293327MR300000293919MR700000294575MR600000295847MR800000296032MR600000296141MR500000296227MR200000296332MR000000296499MR700000296814MR700000296879MR000000297164MR600000297468MR100000297494MR700000297636MR300000297701MR500000297715MR500000297861MR700000298073MR800000298242MR900000298385MR600000298430MR000000298567MR900000298734MR500000298850MR900000299341MR800000299464MR800000299633MR800000300589MR900000301125MR100000301236MR600000301291MR100000301520MR300000301523MR700000301775MR300000301868MR600000302544MR200000302711MR700000302996MR400000303323MR000000303376MR800000303414MR700000303449MR300000303774MR400000304077MR100000304123MR300000304295MR900000304538MR200000304555MR6
- REF 60850 Mfg Lot or Serial #
- Amount recalled
- 1,246 (521 US and 725 OUS)
Where it was sold
Why it was recalled
GE Healthcare has recently become aware of a potential safety issue due to non-unique series identifiers embedded in image headers of certain GE MR Products. For ClariView and Screen Save from GVTK (Gems Visualization ToolKit) Viewer, the MR Product can generate image headers with non-unique series identifiers, which when exported to some PACS systems, results in the series being associated wit
This product could cause temporary or reversible health problems — stop using it.
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