Class 2 Device Recall Signa Infinity Signa Infinity Twinspeed Signa Vibrant Signa HDx Signa HDxt Signa HDxi

Date Initiated by Firm	November 21, 2011
Date Posted	August 09, 2013
Recall Status¹	Terminated ³ on October 22, 2014
Recall Number	Z-1943-2013
Recall Event ID	65133
510(K)Number	K013636 K030874 K040444 K041476 K052293
Product Classification	System, nuclear magnetic resonance imaging - Product Code LNH
Product	SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM GE SIGNA 3.0T WITH EXCITE MR SYSTEM GE SIGNA EXCITE 1.5T MR SYSTEM GE SIGNA EXCITE 3.0T MR SYSTEM Signa HDx Signa HDxt Signa HDi Signa Vibrant GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM (i.e. Signa Ovation 5 and Ovation HD) GE 1.5T SIGNA HDe MR SYSTEM GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM GE 0.7T SIGNA OPENSPEED (4) WITH EXCITE MR SYSTEM GE 0.7T SIGNA OPENSPEED (5) WITH EXCITE MR SYSTEM The GE Signa Infinity line of products are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio and short scan times. The Signa Infinity System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs 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. The images produced by the Signa Infinity systems reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
Code Information	Ref. # 60808 "Products: Signa Infinity MR System with EXCITE Technology, Signa EXCITE 1.5T and Signa EXCITE 3.0T, Signa 3T with EXCITE, Signa 3T Infinity with EXCITE, GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM (Waukesha, WI) FMI 60808" Mfg Lot or Serial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00000296846MR9 00000297381MR6 00000296847MR7 00000296558MR0 00000296863MR4 00000295174MR7 00000241723MR6 00000282690MR7 00000289785MR8 00000298975MR4 00000287024MR4 00000246608MR4 00000256235MR3 00000270514MR3 00000260103MR7 00000264793MR1 00000259582MR5 00000264798MR0 00000270518MR4 00000260097MR1 00000270521MR8 00000260466MR8 00000272564MR6 00000270525MR9 00000256215MR5 00000258395MR3 00000261387MR5 00000264490MR4 00000266697MR2 00000274107MR2 00000268523MR8 00000253152MR3 00000263941MR7 00000264548MR9 00000283317MR6 00000266757MR4 00000279892MR4 00000278667MR1 00000280903MR6 00000273681MR7 00000279083MR0 00000283357MR2 00000280676MR8 00000276248MR2 00000271120MR8 00000274830MR9 00000262456MR7 00000266746MR7 00000283385MR3 00000285384MR4 00000274892MR9 00000283696MR3 00000285023MR8 00000286267MR0 00000275093MR3 00000282911MR7 00000284214MR4 00000261868MR4 00000277195MR4 00000275475MR2 00000275580MR9 00000286149MR0 00000294435MR3 00000011719YR2 00000296360MR1 00000294271MR2 00000286585MR5 00000277641MR7 00000296404MR7 00000294441MR1 00000012014YR7 00000010796YR1 00000299348MR3 00000299451MR5 00000011026YR2 00000299417MR6 00000295056MR6 00000295477MR4 00000294607MR7 00000287122MR6 00000298093MR6 00000011084YR1 00000295014MR5 00000298843MR4 00000297179MR4 00000284904MR0 00000286012MR0 00000287308MR1 00000287396MR6 000000HDMR5258 00000012013YR9 00000294510MR3 00000298097MR7 00000838BD4ECB 00000299494MR5 00000300186MR4 00000294907MR1 00000297973MR0 00000919BD5B86 00000294514MR5 00000011552YR7 000001106XF022 00000295481MR6 00000286290MR2 00000298488MR8 00000296366MR8 00000287389MR1 00000288979MR8 00000288891MR5 00000301039MR4 00000299675MR9 00000273525MR6 00000286282MR9 00000275844MR9 00000262300MR7 00000008340YR2 00000280857MR4 00000286262MR1 00000286686MR1 00000297445MR9 00000299674MR2 00000295513MR6 00001009BD65FE 00000230686MR8 00000257733MR6 00000263945MR8 00000296463MR3 00000266145MR2 00000274693MR1 00000277191MR3 00000277692MR0 00000276153MR4 00000280627MR1 00000276632MR7 00000290191MR6 00000914BD5A7E 00000294436MR1 00001002BD639A 00000286692MR9 00000287113MR5 00000931BD5D7B 00000294274MR6 00000300616MR0 00000300618MR6 00000011731YR7 00000286248MR0 00000288650MR5 00000011775YR4 REF # 67626 "Products: GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM (Signa Ovation 5 and Ovation HD) (Beijing, China) FMI 67626" Mfg Lot or Serial # 000SPI275 138161HM5 154416HM2 167478HM7 169099HM9 171687HM7 176546HM0 188506HM0 192710HM2 193122HM9 202350HM5 213385HM8 226223HM6 238928HM6 241057HM9 266117HM1 139841HM1 210567HM4 150713HM6 160804HM1 162558HM1 164061HM4 165767HM5 172417HM8 172812HM0 172864HM1 173903HM6 177138HM5 177789HM5 178516HM1 179358HM7 180124HM0 181095HM1 181525HM7 182066HM1 182244HM4 182592HM6 183128HM8 187360HM3 188807HM2 189100HM1 191022HM3 191158HM5 196644HM9 200573HM4 202345HM5 204158HM0 205908HM7 206819HM5 210513HM8 213193HM6 214041HM6 214712HM2 215676HM8 216125HM5 217358HM1 218474HM5 219021HM3 219406HM6 222105HM9 223599HM2 224698HM1 224707HM0 228098HM0 229042HM7 230858HM3 231784HM0 234987HM6 242129HM5 243112HM0 244329HM9 245315HM7 245639HM0 250988HM3 252871HM9 256318HM7 257108HM1 262327HM0 265044HM8 267712HM8 270517HM6 270524HM2 271390HM7 271741HM1 157409HM4 148416HM1 174343HM4 175020HM7 199950HM7 205562HM2 218302HM8 155505HM1 212655HM5 155506HM9 195286HM0 223710HM5 231594HM3 233074HM4 157408HM6 147520HM1 189940HM0 198004HM4 198790HM8 224716HM1 245556HM6 224689HM0 229582HM2 199942HM4 181827HM7 227474HM4 226814HM2 214907HM8 239726HM3 241050HM4 223171HM0 247892HM3 271397HM2 271404HM6 271750HM2 276214HM4 146883HM4 158636HM1 147900HM5 169828HM1 170935HM1 190433HM3 191901HM8 193217HM7 193933HM9 195769HM5 197642HM2 224432HM5 259738HM3 270004HM5 144793HM7 150146HM9 221033HM4 170104HM4 181826HM9 195287HM8 208285HM7 219747HM3 220369HM3 247222HM3 257835HM9 221645HM5 168318HM4 181520HM8 220560HM7 Ref # 67815 "Product: GE 0.7T SIGNA OPENSPEED WITH EXCITE MR SYSTEM, (HFO5), (Signa Openspeed 5) (Hino, Japan) FMI 67815D" Mfg Lot or Serial # 00000000102YR4 00000000127YR1 00000000133YR9 00000000142YR0 00000000144YR6 00000000146YR1 00000000149YR5 00000000151YR1 00000000155YR2 00000003011YR4 00000003022YR1 00000003023YR9 00000003024YR7 00000003025YR4 00000003026YR2 00000003027YR0 00000003028YR8 00000003029YR6 00000003030YR4 00000003031YR2 00000003033YR8 00000003034YR6 00000003035YR3 00000003036YR1 00000003039YR5 00000003041YR1 00000003042YR9 00000003043YR7 00000003044YR5 00000003050YR2 00000003051YR0 00000003052YR8 00000003053YR6 00000003049YR4 00000000122YR2 00000003047YR8 "Product: GE 0.7T SIGNA OPENSPEED WITH EXCITE MR SYSTEM (HFO4), (Signa Openspeed 4) CR No. 9612283-XX/XX/XX-00X-C (Hino, Japan) FMI 67815C" Mfg Lot or Serial # 00000000100YR8 00000000109YR9 00000000113YR1 00000000118YR0 00000000119YR8 00000000120YR6 00000000128YR9 00000000129YR7 00000000132YR1 00000000134YR7 00000000136YR2 00000000150YR3 00000000152YR9 00000943610YM6 00000951021YM5 00000962592YM2 00000000124YR8 00000000137YR0 "Product: GE 0.35T SIGNA OVATION WITH EXCITE (MFO4) MR SYSTEM (Signa Ovation 4) CR No. 9612283-XX/XX/XX-00X-C (Hino, Japan) FMI 67815B" Mfg Lot or Serial # 00000000123YR0 00000000125YR5 00000000130YR5 00000000138YR8 00000000139YR6 00000000561YR1 00000000563YR7 00000000564YR5 00000000586YR6 00000000756YR7 00000000757YR5 00000000758YR3 00000000759YR1 00000000760YR9 00000000768YR2 00000000770YR8 00000000771YR6 00000000772YR4 00000000773YR2 00000000775YR7 00000000784YR9 00000000785YR6 00000000786YR4 00000000788YR0 00000000796YR3 00000000798YR9 00000000809YR4 00000000812YR8 00000000816YR9 00000000818YR5 00000000825YR0 00000000826YR8 00000000827YR6 00000000835YR9 00000963007YM0 00000000804YR5 00000000778YR1 00000000779YR9 00000000780YR7 00000000789YR8 00000000790YR6 00000000793YR0 00000000795YR5 00000000799YR7 00000000800YR3 00000000801YR1 00000000803YR7 00000000805YR2 00000000807YR8 00000000808YR6 00000000810YR2 00000000819YR3 00000000828YR4 00000000830YR0 00000000831YR8 00000000832YR6 00000000834YR2 00000000836YR7 00000000837YR5 00000000838YR3 00000000839YR1 00000000840YR9 00000000841YR7 00000000811YR0 00000000140YR4 00000000141YR2 00000000565YR2 00000000763YR3 00000000766YR6 00000000767YR4 00000000769YR0 00000000787YR2 00000000761YR7 00000000116YR4 00000000117YR2 00000000777YR3 00000000143YR8 00000000781YR5 00000000776YR5 00000000765YR8 00000000782YR3 00000000791YR4 00000000823YR5 00000000824YR3 00000000797YR1 00000000794YR8 "Product: GE 1.5T SIGNA HDe MR SYSTEM CR No. 9612283-XX/XX/XX-00X-C (Hino, Japan) FMI 67815A" Mfg Lot or Serial # 00000004984YR1 00000005068YR2 00000005079YR9 00000005080YR7 00000005081YR5 00000005648YR1 00000005656YR4 00000005659YR8 00000005664YR8 00000006155YR6 00000006157YR2 00000006172YR1 00000006176YR2 00000006177YR0 00000006188YR7 00000006194YR5 00000006198YR6 00000006200YR0 00000006204YR2 00000006514YR4 00000006515YR1 00000006516YR9 00000006519YR3 00000006522YR7 00000006525YR0 00000006528YR4 00000006532YR6 00000006535YR9 00000006538YR3 00000006544YR1 00000007947YR5 00000007954YR1 00000007969YR9 00000007970YR7 00000007971YR5 00000008692YR6 00000008698YR3 00000008699YR1 00000008701YR5 00000008703YR1 00000008709YR8 00000008715YR5 00000008716YR3 00000008720YR5 00000008726YR2 00000008727YR0 00000008728YR8 00000008729YR6 00000008732YR0 00000008734YR6 00000009833YR5 00000010024YR8 00000010025YR5 00000010114YR7 00000010578YR3 00000010583YR3 00000010686YR4 00000010794YR6 00000010795YR3 00000010830YR8 00000010831YR6 00000010834YR0 00000010856YR3 00000010863YR9 00000011210YR2 00000011428YR0 00000011429YR8 00000011495YR9 00000011499YR1 00000011637YR6 00000011648YR3 00000011650YR9 00000011669YR9 00000011686YR3 00000011826YR5 00000011829YR9 00000011830YR7 00000011842YR2 00000012085YR7 00000012098YR0 00000012099YR8 00000012100YR4 00000012102YR0 00000012142YR6 00000012172YR3 00000012206YR9 00000012207YR7 00000012221YR8 00000012227YR5 00000012286YR1 00000012287YR9 00000012289YR5 00000012330YR7 00000012393YR5 00000012434YR7 00000012435YR4 00000012503YR9 00000012507YR0 00000012576YR5 00000012651YR6 00000012652YR4 00000012727YR4 00000012728YR2 00000012755YR5 00000012756YR3 00000012818YR1 00000012820YR7 00000012940YR3 00000012943YR7 00000012988YR2 00000012992YR4 00000012994YR0 00000012995YR7 00000013056YR7 00000013061YR7 00000013177YR1 00000013180YR5 00000013185YR4 00000013239YR9 00000013241YR5 00000013246YR4 00000013301YR7 00000013306YR6 00000013310YR8 00000013375YR1 00000013379YR3 00000013384YR3 00000013385YR0 00000013399YR1 00000013453YR6 00000013799YR2 00000013800YR8 00000013802YR4 00000013804YR0 00000013878YR4 00000013880YR0 00000014113YR5 00000014114YR3 00000014214YR1 00000014276YR0 00000014277YR8 00000014520YR1 00000014524YR3 00000014801YR5 00000014806YR4 00000014858YR5 00000014859YR3 00000014909YR6 00000014910YR4 00000014956YR7 00000011535YR2 00000012209YR3 00000014414YR7 00000006174YR7 00000006507YR8 00000010827YR4 00000011960YR2 00000012144YR2 00000012497YR4 00000012575YR7 00000012753YR0 00000012991YR6 00000013693YR7 00000013875YR0 00000014415YR4 00000014419YR6 00000014620YR9 00000006547YR4 00000014907YR0 00000011692YR1 00000012367YR9 00000012508YR8 00000012550YR0 00000012722YR5 00000012942YR9 00000013305YR8 00000013451YR0 00000013626YR7 00000013805YR7 00000013876YR8 00000013877YR6 00000012796YR9 00000007964YR0 00000008704YR9 00000009948YR1 00000010023YR0 00000010685YR6 00000010833YR2 00000011827YR3 00000011824YR0 00000013057YR5 00000006181YR2 00000006183YR8 00000006184YR6 00000006185YR3 00000006186YR1 00000007951YR7 00000007952YR5 00000008688YR4 00000008689YR2 00000008705YR6 00000008706YR4 00000008707YR2 00000008708YR0 00000008710YR6 00000008711YR4 00000008712YR2 00000008730YR4 00000008731YR2 00000008733YR8 00000009832YR7 00000010227YR7 00000010231YR9 00000010250YR9 00000010253YR3 00000010579YR1 00000010754YR0 00000010755YR7 00000010857YR1 00000010860YR5 00000010862YR1 00000011186YR4 00000011211YR0 00000011212YR8 00000011238YR3 00000011290YR4 00000011343YR1 00000011349YR8 00000011537YR8 00000011539YR4 00000011638YR4 00000011639YR2 00000011649YR1 00000011652YR5 00000011653YR3 00000011685YR5 00000011689YR7 00000011690YR5 00000011828YR1 00000011840YR6 00000011961YR0 00000011963YR6 00000011964YR4 00000011987YR5 00000011991YR7 00000011992YR5 00000012103YR8 00000012117YR8 00000012118YR6 00000012119YR4 00000012141YR8 00000012147YR5 00000012171YR5 00000012366YR1 00000012368YR7 00000012389YR3 00000012390YR1 00000012391YR9 00000012449YR5 00000012551YR8 00000012579YR9 00000012580YR7 00000012581YR5 00000012582YR3 00000012723YR3 00000012729YR0 00000012875YR1 00000012876YR9 00000012879YR3 00000012880YR1 00000012936YR1 00000012937YR9 00000012993YR2 00000013055YR9 00000013092YR2 00000013135YR9 00000013238YR1 00000013240YR7 00000013244YR9 00000013245YR6 00000013249YR8 00000013303YR3 00000013309YR0 00000013347YR0 00000013377YR7 00000013397YR5 00000013445YR2 00000013446YR0 00000013448YR6 00000013452YR8 00000013576YR4 00000013577YR2 00000013578YR0 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Recalling Firm/ Manufacturer	GE Healthcare, LLC 3000 N Grandview Blvd Waukesha WI 53188-1615
For Additional Information Contact	262-513-4122
Manufacturer Reason for Recall	Screen save images are included in wrong exam due to duplicate UID creation. This may cause a safety issue due to a potential patient data mismatch.While the issue has only been observed at one customer site on the Signa HDxT 1.5T system, internal investigation revealed that the issue also impacts multiple GE healthcare MR Systems.
FDA Determined Cause ²	Software design
Action	GE Healthcare communicated internally to their Service Team the directions for completing the correction on the customers' systems. GE Healthcare's recall strategy was to update all affected systems that were distributed. At this time,Week of 02/06/2012, deployment of this recall is considered complete. Should you have any questions or require additional information, please contact Regulatory Affairs Leader by telephone at 262-548-2608 or email paulcorrigan@ge.com.
Quantity in Commerce	7016 (2919 US; 4097 OUS)
Distribution	Worldwide distribution: USA (nationwide) including DC and Puerto Rico and countries: ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIDJAN, BELARUS, BELGIUM, BOLIVIA, BOSNIA-HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, GREAT BRITAIN, GREECE, GUADELOUPE, GUATEMALA, GUYANA, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAPAN,JORDAN, KAZAKHSTAN, KENYA, KUWAIT, LATVIA, LEBANON, LIBYA, LITHUANIAN, LUXEMBOURG, MALAYSIA, MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PANAMA, PARAGUAY, PERU. PHILIPPINES, POLAND, PORTUGAL, REPUBLIC OF MACEDONIA, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAK REPUBLIC, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TUNISIA, TUR,EKY, UKRAINE, UNITED ARAB EMIRATES, URUGUAY, VENEZUELA, VIETNAM, YUGOSLAVIA, MALAWI, MAURITANIA, NIGERIA, UKRAINE, IVORY COST, OMAN, ZAMBIA, UZBEKISTAN, ESTONIA, IRAQ, and JAMAICA.
Total Product Life Cycle	TPLC 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) Database	510(K)s with Product Code = LNH and Original Applicant = GE MEDICAL SYSTEMS 510(K)s with Product Code = LNH and Original Applicant = GE MEDICAL SYSTEMS, LLC 510(K)s with Product Code = LNH and Original Applicant = GENERAL ELECTRIC CO.

Class 2 Device Recall Signa Infinity Signa Infinity Twinspeed Signa Vibrant Signa HDx Signa HDxt Signa HDxi

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