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U.S. Department of Health and Human Services

Class 2 Device Recall GE Signa Ovation 0.35 T MR System

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 Class 2 Recall
GE Signa Ovation 0.35 T MR System
see related information
Date Posted June 30, 2009
Recall Status1 Open
Recall Number Z-1556-2009
Recall Event ID 52015
Premarket Notification
510(K) Numbers
K032795  K053009 
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
Product GE Signa Ovation 0.35 T MR System. The Signa Ovation System is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times.
Code Information Model Numbers: 2276937, 2377062-8, 2377062-5 and unknown. Serial Numbers: 00000157798HMO 000, 00000965785YM9 000, 00000000792YR2 000, 00000120261HM3 000, 00000965791YM7 000, 00000965789YM1 000, 00000965774YM3 000, 00000965767YM7 000, 00000952558YM5 000, 00000161742HM2 000, 00000965783YM4 000, 00000897698YM7 000, 00000965839YM4 000, 00000143534HM6 000, 00000120262HM1 000, 00000965865YM9 000, 00000952554YM4 000, 00000965793YM3 000, 00000965838YM6 000, 00000118303HM7 000, 00000156888HM0 000, 00000148896HM4 000, 00000965831YM1 000, 00000965836YM0 000, 00000897715YM9 000, 00000153107HM8 000, 00000115229HM7 000, 00000153105HM2 000, 00000897705YM0 000, 00000153106HM0 000, 00000952552YM8 000, 00000121313HM1 000, 00000919515YM7 000, 00000151429HM8 000, 00000118304HM5 000, 00000965857YM6 000, 00000919510YM8 000, 00000121314HM9 000, 00000115787HM4 000, 00000965768YM5 000, 00000965841YM0 000, 00000952548YM6 000, 00000952564YM3 000, 00000965840YM2 000, 00000144330HM8 000, 00000952555YM1 000, 00000122089HM6 000, 00000000793YR0 000, 00000151428HM0 000, 00000115786HM6 000, 00000145610HM2 000, 00000952549YM4 000, 00000965837YM8 000, 00000952566YM8 000, 00000952550YM2 000, 00000965835YM2 000, 00000144331HM6 000, 00000123637HM1 000, 00000919518YM1 000, 00000869950YM6 000, 00000919511YM6 000, 00000000766YR6 000, 00000000787YR2 000, 00000897711YM8 000, 00000897717YM5 000, 00000869948YM0 000, 00000000767YR4 000, 00000000141YR2 000, 00000869964YM7 000, 00000000763YR3 000, 00000869965YM4 000, 00000000769YR0 000, 00000000140YR4 000, 00000965815YM4 000, 00000965777YM6 000, 00000965776YM8 000, 00000919509YM0 000, 00000801193YM4 000, 00000965834YM5 000, 00000801203YM1 000, 00000801199YM1 000, 00000965811YM3 000, 00000897714YM2 000, 00000813957YM8 000, 00000837348YM2 000, 00000965842YM8 000, 00000813955YM2 000, 00000000776YR5 000, 00000965819YM6 000, 00000000824YR3 000, 00000837353YM2 000, 00000000823YR5 000, 00000000791YR4 000, 00000965844YM4 000, 00000869958YM9 000, 00000000797YR1 000, 00000897712YM6 000, 00000965853YM5 000, 00000813944YM6 000, 00000965775YM0 000, 00000144942HM0 000, 00000952559YM3 000, 00000813948YM7 000, 00000869966YM2 000, 00000801209YM8 000, 00000813950YM3 000, 00000000758YR3 000, 00000813945YM3 000, 00000801208YM0 000, 00000801206YM4 000, 00000000123YR0 000, 00000801200YM7 000, 00000869959YM7 000, 00000952561YM9 000, 00000813958YM6 000, 00000000755YR9 000, 00000837350YM8 000, 00000142796HM2 000, 00000000756YR7 000, 00000000138YR8 000, 00000813960YM2 000, 00000897703YM5 000, 00000965825YM3 000, 00000965858YM4 000, 00000000130YR5 000, 00000919526YM4 000, 00000000784YR9 000, 00000837365YM6 000, 00000965846YM9 000, 00000125239HM4 000, 00000965780YM0 000, 00000000788YR0 000, 00000869963YM9 000, 00000837352YM4 000, 00000837364YM9 000, 00000813959YM4 000, 00000801204YM9 000, 00000000773YR2 000, 00000952565YM0 000, 00000965855YM0 000, 00000813947YM9 000, 00000869955YM5 000, 00000145536HM9 000, 00000869949YM8 000, 00000000786YR4 000, 00000965832YM9 000, 00000919519YM9 000, 00000965864YM2 000, 00000965864YM2 000, 00000837359YM9 000, 00000919516YM5 000, 00000897706YM8 000, 00000837347YM4 000, 00000869956YM3 000, 00000919517YM3 000, 00000000768YR2 000, 00000952563YM5 000, 00000869947YM2 000, 00000000762YR5 000, 00000965812YM1 000, 00000965787YM5 000, 00000897700YM1 000, 00000801202YM3 000, 00000000760YR9 000, 00000123337HM8 000, 00000965845YM1 000, 00000837362YM3 000, 00000801190YMO 000, 00000123954HM0 000, 00000143000HM8 000, 00000965828YM7 000, 00000148077HM1 000, 00000000770YR8 000, 00000965778YM4 000, 00000000139YR6 000, 00000837360YM7 000, 00000952547YM8 000, 00000869954YM8 000, 00000869952YM2 000, 00000837346YM6 000, 00000919514YMO 000, 00000965829YM5 000, 00000919524YM9 000, 00000141650HM2 000, 00000125261HM8 000, 00000919521YM5 000, 00000965810YM5 000, 00000965860YM0 000, 00000897699YM5 000, 00000837351YM6 000, 00000813943YM8 000, 00000919512YM4 000, 00000869961YM3 000, 00000000772YR4 000, 00000952556YM9 000, 00000919507YM4 000, 00000813956YM0 000, 00000801197YM5 000 and 00000813949YM5 000.
Recalling Firm/
Manufacturer
GE Medical Systems, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer Reason
for Recall
GE Healthcare has identified a potential safety issue with the Signa OpenSpeed and Signa Ovation MR Scanner tables that may impact patient safety. The table may begin lowering on its own while a patient is on the table. If this occurs while the table is in the magnet bore, the table may tilt and could result in patient injury. The patient's head or feet depending on patient orientation, may hit
FDA Determined
Cause 2
DESIGN: Device Design
Action GE Healthcare issued an "Urgent Medical Device Correction" letter dated April 16, 2009 addressed to Hospital Administrators, Mangers of Radiology/Cardiology and Radiologists/Cardiologists. The letter describes the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. A GE Healthcare Field Engineer will schedule a field visit to correct the device. Further questions or concerns may be addressed to GE Healthcare at 1-262-521-6681.
Quantity in Commerce 203
Distribution Worldwide Distribution -- US including PR and states of AL, AZ, AR, CA, CO,CT, DE, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MN, MS, MO,MT, NV, NH, NE, NJ, NY, NC, OH, OK,OR, PA, SC, SD, TN, TX, VA, WA, WV, WI and countries of BRAZIL CHINA, DENMARK, EGYPT, ENGLAND, GERMANY, GUATEMALA, HUNGARY, ITALY, IVORY COAST, JAPAN, KOREA, KUWAIT, OMAN, MEXICO, OMAN, PHILIPPINES, RUSSIAN FEDERATION, SPAIN, SWITZERLAND, TURKEY, UNITED ARAB EMIRATES 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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