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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 Initiated by Firm September 08, 2008
Date Posting Updated April 10, 2009
Recall Status1 Terminated 3 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 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 F.I. HAIFA
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