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U.S. Department of Health and Human Services

Class 2 Device Recall GE 1.5T and 3.0T SIGNA Excite, Twinspeed, Infinity, and HDx MRI systems

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 Class 2 Device Recall GE 1.5T and 3.0T SIGNA Excite, Twinspeed, Infinity, and HDx MRI systemssee related information
Date Initiated by FirmJuly 10, 2015
Date PostedAugust 05, 2015
Recall Status1 Terminated 3 on November 19, 2015
Recall NumberZ-2339-2015
Recall Event ID 71788
510(K)NumberK012200 K013636 K030874 K040444 K041476 
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
ProductGE Healthcare, Signa Infinity MR System; Signa MR/i MR System; SmartSpeed; EchoSpeed Plus; HighSpeed Plus, Signa Infinity MR System with EXCITE Technology, Excite II, Signa 3T Infinity with Excite, Signa Excite 1.5T and Signa Excite 3T, Signa Excite HD, Signa HD 1.5T and Signa HD 3.0T, Signa HDx, Signa HDxt, Signa HDi. Whole body magnetic resonance diagnostic imaging scanners.
Code Information  Mfg Lot or Serial # System ID 00000153282MR9 501362MR1 00000165901MR0 ZA2101MR02 00000213818MR8 37190MRI 00000213341MR1 M27590 00000247386MR6 707459MR2 00000231538MR0 706583MR 00000236418MR0 850862FTS1CH1 00000242668MR2 502868MR 00000267704MR5 314525SAMR2 00000227724MR2 ALLIANCESIG262 00000214667MR8 853270051 00000242173MR3 ALLIANCESIG287 00000241518MR0 502633MR1 00000231910MR1 212956MR2 00000237000MR5 0910272037 00000241867MR1 HU1008MR01 00000243769MR7 920279006 00000047514WH5 YM0774 00000285490MR9 954916MR1 00000284687MR1 309655MRI1A 00000280860MR8 1202470 00000282692MR3 902496MRI3 00000282813MR5 0835270010 00000278669MR7 508755MR1 00000267211MR1 0850270458 000000HDMR3141 SHIMR598 000000HDMR5777 919470MR2 000000HDMR3905 709737MRI 000000HDMR2541 M4018076 000000HDMR5379 M4135138 00000HDMR10710 10543MRM01 00000301019MR6 SMSDML2 00000292334MR0 INSIGHTMR1915 00000290735MR0 704323MR1 00000300812MR5 MR14604YR3 00000297420MR2 082427080028 00000239401MR3 404352PNC 00000209414MR2 732591MR 00000206394MR9 516365MR 00000224271MR7 RADNETMR1515 00000190316MR0 1167491 00000223494MR6 1299290 00000223256MR9 84631 00000227239MR1 2817688 00000230273MR5 2817679 00000240274MR1 083027002100393 00000199094MR4 YM0620 00000237547MR5 600101MR01 00000210080MR8 941262MR 00000214332MR9 208367LX5 00000204255MR4 770438EAMR 00000218279MR8 2214SIGNA15 00000215878MR0 0853270047 00000193672MR3 AE1011MR01 00000001634M25 MRR8049 00000005464M23 082427070113 00000000108M21 2807539 00000267104MR8 864225MR 00000254183MR7 304347MR1 00000264011MR8 EG1522MR01 00000006705YR8 901226MR1 00000007870YR9 2651831 00000009552YR1 FI1012MR04 00000009010YR0 FI1012MR03 00000006662YR1 0850270197 002003-0922-09 ALLIANCESIG293 0002005-0725-4 5360MREXCITE3 00000279502MR9 304766TMR 00000284315MR9 208265BMR 00000285664MR9 904399MR2 00000280274MR2 561798MR1 00000286778MR6 2718385 00000276273MR0 4716MREXCITE 00000299465MR5 EG1279MR01 00000309342MR4 082427010077 00000264527MR3 SMSFFI2 00000263933MR4 A5156029 00000266764MR0 RADNETMR1513 00000291209MR5 415780KMR 00000290984MR4 214820XBMR1  928649MR  08302703148203                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 
Recalling Firm/
Manufacturer		 GE Healthcare
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
800-437-1171
Manufacturer Reason
for Recall		A gradient cable in the ACGD cabinet may be missing a spacer that prevents connecting the gradient cable terminals in the wrong polarity on X gradient amplifier. This could cause images to be flipped left-right with incorrect orientation annotation.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionGE Healthcare sent an Urgent Medical Device Correction letter dated July 10, 2015, to all affected consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. Consignees with questions were instructed to contact GE Healthcare Service at 1-800-437-1171 or their local Service Representative.
Quantity in Commerce82 (39 USA; 43 OUS)
DistributionWorldwide Distribution - US (nationwide) and Internationally to UNITED ARAB EMIRATES, ARGENTINA, BRAZIL, INDIA, EGYPT, CHINA, FINLAND, FRANCE, UNITED KINGDOM, HUNGARY, JAPAN, INDONESIA, KOREA, MEXICO, NEW ZEALAND, CANADA, AUSTRALIA, ITALY, RUSSIAN FEDERATION, TAIWAN, and SOUTH AFRICA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LNH
510(K)s with Product Code = LNH
510(K)s with Product Code = LNH
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