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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 Posted April 10, 2013
Recall Status1 Terminated 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 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 = 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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