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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm March 06, 2012
Date Posting Updated April 10, 2013
Recall Status1 Terminated 3 on January 27, 2014
Recall Number Z-1078-2013
Recall Event ID 64398
510(K)Number K022960  K991841  K052434  
Product Classification System, tomography, computed, emission - Product Code KPS
Product GE Healthcare Quasar Nuclear Medicine System, Hawkeye Option and Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera. Nuclear Medicine imaging systems. Recall includes all Infinia systems, all configurations.
Code Information 426150014, 415300IN, 513636INF, 402559INF2, 916781IN, 415353IN, 916703IN1, 787758INFINIA2, 78NMIH2564713, 0920269081, 0920269079, NO1000MN03, NO1070MN07, AMS0338, INF2649553, 2660585INF, 2633201INF, YN1744, YN1743, YN1745, YN1742, A5547414, A5152964, A5114292, A5107756, B5357630, 083026202100317, 083026842101817, IL1028NM26, 0828260007, IE1564NM01, 2612588INF2H, DK1026NM07, 427459NU02, 2585033INF, 519685INFINIA2, 506544NUCGE, 2775945, 2555007, AH3701NM05, A5172908, 209831IN, 671USNHINF, 903416INF, YN1650, YN1641, A5649008, A5216823, A5128757, A5124139, H2100NUC02, 080004NU11, A5224207, 919684INF2, 650858IN2, 600092NM10, PL1003NM03, 4716INFINIAHE4, YN4830, YN4900, YN4820, YN4249, YN4819, YN4818, YN4825, 083026006866397, 083026002000938, 2721482INF, 082426100035, 082426270007, 082426050005, 082426090022, 082426190017, 082426120018, 082426230016, 082426160035, 082426100032, 082426040042, 082426170003, 082426140022, 082426070025, 082426210017, 082426120019, 082426110008, 082426290006, 082426140019, 082426230015, 082426070023, 082426100038, 082426090024, 082426140018, 082426100041, 082426090017, 082426160033, 082426090020, 082426160031, 082426310022, 082426100043, 082426130027, 082426090021, 082426080019, 082426110006, 082426070024, 082426080018, 082426310021, 1299296, 2769200, AH5844NM05, 519749INFINIA2, 082426310016, 082426120021, 082426130038, H010NU04, E001NU16, NO1054MN01, NO1116MN09, DHG0539, A5181660, 00439NUC08, 220826NU01, ZA1835NM25, 703558INF, 214820INF2, 718584INFINIA, 610402INFINIA, 402354HWK, 920272INF2, 713785SLINF3, 0920269082, 2864298INF, 0850260109, 0850260084, 0828260017, 0828260018, 0828260013, 2694427INF, 2646005INF, 819563CINFINIA, 403229INFINIA, 905358INFINIA, 204787INFINIA, 250754INFINIA, 250754INFINIA2, 613761INFINIA, 082426150021, 082426160032, 2760723, 0910264067, 0910264069, 0910264098, 0910266045, 0910264060, 787848INFINIA, 773884INF, 210575INF1.
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
Accelerated fatigue of the lateral axis motion subsystem of the Infinia Computed Emission Tomography System could result in mechanical failure causing the detector to slide; may impact patient and operators.
FDA Determined
Cause 2
Process control
Action GE Healthcare sent an " IMPORTANT PRODUCT INFORMATION" letter dated March 6, 2012. The letter was addressed to Managers of Nuclear Medicine, Hospital Administrators / Risk Managers and Managers of Radiology/Cardiology. The letter described the Issue, instructions, Affected Product Details, and Product Correction. For questions contact your local GE Healthcare Service Representative or call the GE Healthcare Call Center: United States or Canada: 800-437-1171 and Other Countries 262-896-2890.
Quantity in Commerce 2180
Distribution Worldwide Distribution - USA (nationwide) including DC and PR and the countries of UKRAINE, TAIWAN, TURKEY, TUNISIA, THAILAND, SINGAPORE, SWEDEN, SAUDI ARABIA, RUSSIAN FEDERATION, PORTUGAL, POLAND, PAKISTAN, PHILIPPINES, PANAMA, NEW ZEALAND, NORWAY NETHERLANDS, MALAYSIA, MEXICO, MALTA, MARTINIQUE, MOROCCO, LATVIA, LITHUANIA, LEBANON, KUWAIT, KOREA, JAPAN, JORDAN, ITALY, IRAN, INDIA, ISRAEL, IRELAND, INDONESIA, HUNGARY, CORATIA, HONG KONG, GREECE, GEORGIA, UNITED KINGDOM, FRANCE, FINLAND, SPAIN, EGYPT, ECUADOR, ALGERIA, DOMINICAN REPUBLIC, DENMARK, GERMANY, CZECH REPUBLIC, CYPRUS, COLUMBIA, CHILE, SWITZERLAND, CANADA, CHINA, BRAZIL, BELGIUM, AUSTRALIA, AUSTRIA, ARGENTINA, SOUTH AFRICA, VENEZUELA, URUGUAY, ALGERIA.
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 = KPS and Original Applicant = GE MEDICAL SYSTEMS
510(K)s with Product Code = KPS and Original Applicant = GE MEDICAL SYSTEMS F.I. HAIFA
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