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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare Signa Ovation 0.35T

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 Class 2 Recall
GE Healthcare Signa Ovation 0.35T
see related information
Date Posted August 25, 2009
Recall Status1 Open
Recall Number Z-1722-2009
Recall Event ID 51314
Premarket Notification
510(K) Numbers
K032795  K053009 
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
Product GE Healthcare Signa Ovation 0.35T, Model Numbers: Ovation 1-3 (2276937), Ovation 4 (2377062-2, 2377062-5, 2377062-8, or 5118172), and Ovation 5 (5148725). The 0.35T Signa Ovation with Excite Magnetic Resonance system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The 0.35T Signa Ovation with Excite Magnetic Resonance system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the body including, but not limited to, the musculoskeletal, vascular, cardiac, and neuron systems.
Code Information Model Number: 2276937; Serial Numbers: 00000869965YM4, 00000801207YM2, 00000813952YM9, 00000952559YM3, 00000236062MR6, 00000869966YM2, 00000801206YM4, 00000813945YM3, 00000813950YM3, 00000869958YM9, 00000952561YM9, 00000813958YM6, 00000919518YM1, 00000813944YM6, 00000837353YM2, 00000813960YM2, 00000837350YM8, 00000264247MR1, 00000897708YM4, 00000897716YM7, 00000919512YM4, 00000919526YM4, 00000026540VE5, 00000919509YM0, 00000813959YM4, 00000801204YM9, 00000813947YM9, 00000952560YM1, 00000952565YM0, 00000897711YM8, 00000897717YM5, 00000919515YM7, 00000952552YM8, 00000813951YM1, 00000897701YM9, 00000869949YM8, 00000837359YM9, 00000919519YM9, 00000813946YM1, 00000869956YM3, 00000897706YM8, 00000952563YM5, 00000869947YM2, 00000801199YM1, 00000801193YM4, 00000837362YM3, 00000952548YM6, 00000952549YM4, 00000837360YM7, 00000952547YM8, 00000837346YM6, 00000869952YM2, 00000869954YM8, 00000919514YMO, 00000919524YM9, 00000837358YM1, 00000919521YM5, 00000869962YM1, 00000919513YM2, 00000897705YM0, 00000952555YM1, 00000813943YM8, 00000869961YM3, 00000813956YM0, 00000801203YM1, 00000801208YM0, 00000801209YM8, 00000813948YM7, 00000813953YM7, 00000813954YM5, 00000837347YM4, 00000837351YM6, 00000837352YM4, 00000837354YM0, 00000837357YM3, 00000837361YM5, 00000837363YM1, 00000837364YM9, 00000837365YM6, 00000869950YM6, 00000869951YM4, 00000869953YM0, 00000869955YM5, 00000869957YM1, 00000869960YM5, 00000869963YM9, 00000897698YM7, 00000897699YM5, 00000897700YM1, 00000897702YM7, 00000897703YM5, 00000897704YM3, 00000897707YM6, 00000897715YM9, 00000919507YM4, 00000919510YM8, 00000919516YM5, 00000919517YM3, 00000919520YM7, 00000919523YM1, 00000952550YM2, 00000952553YM6, 00000952557YM7, 00000952558YM5, 00000952562YM7, 00000952566YM8, 00000952554YM4, 00000919511YM6, 00000869948YM0, 00000897714YM2, 00000813957YM8, 00000813955YM2, 00000897712YM6, 00000813949YM5; Model Number: 5118172; Serial Numbers; 00000000564YR5, 00000000565YR2, 00000000563YR7, 00000000561YR1; Model Number: 2377062-2; Serial Number: 00000963007YM0; Model Number: 2377062-5; Serial Numbers: 00000000120YR6, 00000000123YR0, 00000000132YR1, 00000000124YR8, 00000000137YR0, 00000000130YR5, 00000000134YR7, 00000000138YR8, 00000962592YM2, 00000000146YR1, 00000000117YR2, 00000000116YR4, 00000000118YR0, 00000943610YM6, 00000000152YR9, 00000000140YR4, 00000000110YR7, 00000000135YR4, 00000000106YR5, 00000000129YR7, 00000000141YR2, 00000000125YR5, 00000000142YR0, 00000000113YR1, 00000000150YR3, 00000000105YR7, 00000000131YR3, 00000000139YR6, 00000000155YR2, 00000000108YR1, 00000000143YR8, 00000000101YR6, 00000000109YR9, 00000000153YR7, 00000951021YM5, 00000000119YR8, 00000000136YR2, 00000000128YR9, 00000000100YR8, 00000000112YR3, 00000000121YR4, 00000000154YR5; Model Number: 2377062-8; Serial Numbers: 00000000776YR5, 00000000792YR2, 00000000793YR0, 00000000801YR1, 00000000803YR7, 00000000829YR2, 00000000836YR7, 00000000758YR3, 00000000765YR8, 00000000755YR9, 00000000756YR7, 00000000774YR0, 00000000784YR9, 00000000785YR6, 00000000798YR9, 00000000827YR6, 00000000816YR9, 00000000779YR9, 00000000828YR4, 00000000789YR8, 00000000838YR3, 00000000773YR2, 00000000788YR0, 00000000796YR3, 00000000763YR3, 00000000766YR6, 00000000767YR4, 00000000787YR2, 00000000790YR6, 00000000800YR3, 00000000834YR2, 00000000840YR9, 00000000830YR0, 00000000832YR6, 00000000786YR4, 00000000764YR1, 00000000775YR7, 00000000818YR5, 00000000768YR2, 00000000757YR5, 00000000760YR9, 00000000762YR5, 00000000783YR1, 00000000809YR4, 00000000782YR3, 00000000812YR8, 00000000826YR8, 00000000835YR9, 00000000770YR8, 00000000771YR6, 00000000825YR0, 00000000759YR1, 00000000821YR9, 00000000841YR7, 00000000831YR8, 00000000808YR6, 00000000823YR5, 00000000824YR3, 00000000772YR4, 00000000810YR2, 00000000837YR5, 00000000769YR0, 00000000815YR1, 00000000833YR4, 00000000804YR5, 00000000778YR1, 00000000780YR7, 00000000795YR5, 00000000799YR7, 00000000805YR2, 00000000807YR8, 00000000819YR3, 00000000839YR1, 00000000811YR0, 00000000761YR7, 00000000777YR3, 00000000781YR5, 00000000791YR4, 00000000797YR1, 00000000794YR8; and Model Number: 5148725; Serial Numbers: 00000154413HM9, 00000176551HM0, 00000139846HM0, 00000192389HM5, 00000177143HM5, 00000193109HM6, 00000148905HM3, 00000147526HM8, 00000138166HM4, 00000000SPI275, 00000188489HM9, 00000167482HM9, 00000169104HM7, 00000171692HM7, 00000157419HM3, 00000266430MR8, 00000155516HM8, 00000155515HM0, 00000160809HM0, 00000175023HM1, 00000150718HM5, 00000162563HM1, 00000164072HM1, 00000165772HM5, 00000172421HM0, 00000172816HM1, 00000172869HM0, 00000173908HM5, 00000177792HM9, 00000178519HM5, 00000179361HM1, 00000180127HM3, 00000180746HM0, 00000182071HM1, 00000182249HM3, 00000182597HM5, 00000183130HM4, 00000187365HM2, 00000188810HM6, 00000189105HM0, 00000191017HM3, 00000191154HM4, 00000196647HM2, 00000200577HM5, 00000265078MR6, 00000157418HM5, 00000174348HM3, 00000189943HM4, 00000181736HM0, 00000146891HM7, 00000158641HM1, 00000147906HM2, 00000169833HM1, 00000170940HM1, 00000190359HM0, 00000191544HM6, 00000193220HM1, 00000193936HM2, 00000195772HM9, 00000144797HM8, 00000150152HM7, 00000170109HM3, 00000181735HM2, 00000197645HM5, 00000168323HM4 and 00000181517HM4.
Recalling Firm/
Manufacturer
GE Medical Systems, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
GE Healthcare has identified a potential pinch point hazard on Ovation MR Scanner when using CTL Array XL Body Flex and Opened Body coil. A patient's hand may be pinched between the magnet bore ceiling cover and the CTL Array, XL Body Flex, or Open Body coil if the patient puts his/her hand on the top of the coil. 2/20/09: Recall being expanded to include the OpenSpeed Systems.
FDA Determined
Cause 2
DESIGN: Device Design
Action GE Healthcare issued a "Product Safety Notification" letter dated October 23, 2008. The letter was addressed to Hospital Administrators, Mangers of Radiology/Cardiology & Radiologists/Cardiologists. The letter described the Safety Issue, Affected Product, Safety Instructions, Product Correction and Contact Information for the Signa Ovation 0.35T Systems. A second GE Healthcare "Urgent Medical Device Correction" letter dated March 5, 2009 was sent 3/9/09 to consignees which addressed the expanded recall to the Signa OpenSpeed0.7T MR Systems. For further questions, contact your local GE Healthcare sales or service representative.
Quantity in Commerce 308 (143 US / 142 OUS / 23 TBD)
Distribution Worldwide Distribution-- US (including states of AL, ALZ, AR, CA, CO,CT, DE, FL, FA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MT, MO, NE,NH, NV, NJ, NY, NC, OH, OK, OR, PA, PR, SC SD, TN, TX, VA, WA, WV and WI), CHINA, CYPRUS, ARGENTINA, BRAZIL EGYPT, DENMARK, FEDERAL REPUBLIC OF GERMANY, FEDERAL REPUBLIC OF FRANCE, GET 7 D CHINA, GREECE, HUNGARY, ITALY, IVORY COAST, JAPAN, KOREA, KUWAIT, MALAWI, MEXICO, OMAN, PANAMA, PHILIPPINES, RUSSIAN FEDERATION, SAUDI ARABIA, SPAIN , SWITZERLAND, TURKEY, UKRAINE, UNITED ARAB EMERITUS, UNITED KINGDOM and VENEZUELA.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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
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