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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 Recall
GE Healthcare Infinia Hawkeye 4
see related information
Date Posted April 10, 2009
Recall Status1 Open
Recall Number Z-1095-2009
Recall Event ID 50990
Premarket Notification
510(K) Numbers
K022960  K991841 
Product Classification System, Tomography, Computed, Emission - 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, Wisconsin 53188-1615
Consumer Instructions Contact the recalling firm for information
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
DESIGN: Software Design (Manufacturing Process)
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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