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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare Infinia Hawkeye 4

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 Class 2 Device Recall GE Healthcare Infinia Hawkeye 4 see related information
Date Posted April 10, 2009
Recall Status1 Terminated on May 24, 2012
Recall Number Z-1095-2009
Recall Event ID 50990
510(K)Number K022960 
Product Classification Emission computed tomography system - Product Code KPS
Product GE Healthcare Infinia Hawkeye(R) 4, Model numbers:
H3000WC
H3000WD

Intended use: To perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications.
Code Information H3000WC : S/N
17032
17391
16844
17215
16974
16979
17090
16898
16967
17136
17057
17130
17121
17337
17298
17376
17208
17114
16876
17164
17247
17276
17286
17293
17317
17070
17391
17220
16905
17011
16850
16947
17347
17082
16880
16910
17288
16933
17061
17198
16994
17265
16820
17106
17058
17047
17053
17116
16852
17169
17169
17029
17195
17169
16938
17125
16970
16774
17226
16886
17118
16945
17348
16924
16888
16811
17122
17389
17020
17135
16962
17101
16849
17233
17137
17300
17299
17268
16960
17326
17050
17269
17131
17204
17349
17034
17005
17213
17301
17019
16987
17108
17088
17166
17287
17099
17023
16927
17328
17174
17042
16821
16914
16972
17285
17323
17104
17241
17258
17249
17109
16977
16946
16975
17162
17002
16862
16869
17219
16887
16950
16949
16874
17147
16965
16889
17290
17055
17185
16966
17046
17112
17041
17289
17178
17103
17139
17260
16986
17000
17105
17390
17331
17098
17297
17052
17089
17373
17264
16871
17199
17190
17124
17382
16925
17159
17062
17372
16944
17173
17388
16885
17254
17187
17278
16934
16901
17231
17295
16932
16893
17025
17100
16878
16955
17360
16921
16922
16838
16876
16865
16926
16856
16928
16930
17333
17018
17363
17277
16968
17024
17210
17172
17251
17197
16911
16978
17049
16919
17338
17179
17259
17248
17351
17238
17165
17048
17206, and
17158.

H3000WD:
17154
17310
17113
17072
17163
17236
17067
17067
17107
17346
17252
17126, and
17379.

Recalling Firm/
Manufacturer
GE Medical Systems, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-544-3894
Manufacturer Reason
for Recall
There is a possibility for misregistration when brain scans are performed with Infinia with the Hawkeye option. This misregistration could present the potential for misdiagnosis when the patient headrest sags under the weight of a head.
FDA Determined
Cause 2
Software design
Action Consignees were sent from September 2008 - Feb 2009 a GE "Product Safety Notification" letter dated 4/2008. The letter was addressed to Hospital Administrators, and Managers of Radiology/Cardiology, Radiologists/Cardiologists. The letter described the Safety Issue, Affected Product, Safety Instructions, Product Correction and Contact Information. It instructed consignees to continue to use the Infinia Hawkeye system normally for all types of Hybrid scans and stated that as a general practice tomograms should be reviewed carefully using the Xeleris Volumetrix processing protocol to ensure proper registration. Local sales or service reps should be contacted for further information regarding the notification.
Quantity in Commerce 83 US, 139 OUS
Distribution Worldwide Distribution -- USA including states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, DC, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK ,OR, PA, PR, SD, TN, TX, UT, VT, VA, WA, WV, and WI and countries of AUSTRALIA, BELGIUM , BRASIL, CANADA, CHINA, COLUMBIA, CZECH REPUBLIC, DENMARK, ECUADOR, FINLAND, FRANCE, GEORGIA, GERMANY, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, KOREA, MEXICO, NETHERLANDS, NEW Zealand, NORWAY, POLAND, PUERTO RICO, RUSSIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UKRAINE, UNITED KINGDOM.
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 F.I. HAIFA
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