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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare Infinia Hawkeye

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 Class 2 Device Recall GE Healthcare Infinia Hawkeye see related information
Date Posted April 10, 2009
Recall Status1 Terminated on May 24, 2012
Recall Number Z-1094-2009
Recall Event ID 50990
510(K)Number K022960 
Product Classification Emission computed tomography system - Product Code KPS
Product GE Healthcare Infinia Hawkeye(R), Model numbers:
H2508PY
H3000WN
H3000WR
H3000WW
H3000WY
H3000WZ
H3000YM
H3000YS

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 H2508PY : S/N
16076
16010
16177, and
16175.

H3000WN: 16433 and 16366

H3000WR: 16275, 16306, and 16379.


H3000WW: 16584
16690
16146
16328
16292
16530
16574
16619
16321
16545
16586
16193
16351
16393
16435
16439
16471
16217
16274
16459
16438
17022
16347
16302
16717
16689
16989
16998
17039
16480
16584
16593
16568
16458
16951
16711
16417
16906
17038
16458
16727
16003
16247
16386
16729
16402
16402
16398
16529
16708
16708
16277
16754
16294
16604
16591
16642
16383
16383
16463
16268
16554
16690
16467
16357
16316
16879
16367
16745
16535
16675
16581
16399
16501
16507
16222
16461
16602
16769
16782
16956
16836
16445
16445
16493
16384
16486
16693
16894
16343
16452
16801
16631
16633
16931
16631
16618
16200
16702
16818
16341
16556
16299
16345
16329
16753
16348
16257
16610
16258
16707
16369
16253
16958
16284
16703
16252
16638
16254
16278
16333
16231
16368
16709
16265
16488
16884
16330
16845
16558
16630
16490
16855
16563
16599
16431
16414
16714
16327
16360
16647
16577
16883
16625
16605
16605
16201
16892
16603
16652
16623
16339
16671
16270
16407
16476
16416
16390
16451
16424
16952
16276
16236
16496
16895
16484
16654
16620
16230
16406
16985
16359
16273
16597
16482
16429
16338
16338
16607
16388
16847
16573
16606
16824
16472
16981
16374
16835
16562
16288
16241
16609
16203
16508
16342
16363
16444
16260
16678
16342
16202
16598
16550
16615
16440
16362
16506
16272
16389
16936
16332
16508
16521
16687
16629
16588
16700
16358
16307
16432
16595
16997
16787
16590
16653
16580
16287
16514
16515
16555
16777
16192
16555
16199
16385
16764
16544
16232
16523
16256
16954
16954
16982
16309
16242
16242
16257
16644
16797
16267
16283
16280
16549
16596
16637
16691
16697
16757
16980
16681
16684
16679
16730
16546
16352

H3000WY: 16616
17083
16282
16897
16532
16143
16423
16204
17085
16423, and
16289.

H3000WZ: 16350
16752
16375
16582
16237
16238
16183
16176
16403
16468
17148
16239
16349
16572
16996
16086
16240
16552
16485
16815
16813
16826
17079
16601
16495
16522
16240
16264
16248
16624
16961
16780
16409
16205
16387
16487
16481
16891
16449
16361
16215
16831
16462
16261
16512
16578
16197
16205
16565
16430
16397, and
16251.
H3000YM: 16146
16057
16133
16100
16157
16172
16024
16174
16147
16125
16164
16120
16131
16127
16132
16040
16024
16128
16052
16055
16070
16013
16011
16029
16110
16028
16009
16060
16173
16008
16082
16027
16151
16153
16154
16064
16163
16007
16030
16037
16124
16046
16020
16112
16121
16103
16063
16169
16035
16042
16059
16109
16021
16159
16062
16073
16073
16148
16149
16156
16053
16053
16038
16019
16023
16078
16150, and
16101.

H3000YS: 16061
16134
16095
16085
16152
16089
16074
16168
16141
16067
16068, and
16056.





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 153 US, 264 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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