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U.S. Department of Health and Human Services

Class 2 Device Recall GE QUASAR NUCLEAR MEDICINE SYSTEM

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 Class 2 Recall
GE QUASAR NUCLEAR MEDICINE SYSTEM
see related information
Date Posted April 10, 2009
Recall Status1 Open
Recall Number Z-1121-2009
Recall Event ID 50927
Premarket Notification
510(K) Number
K022960 
Product Classification System, Tomography, Computed, Emission - Product Code KPS
Product GE Healthcare, Infinia Hawkeye® 4, Model Numbers: 5178728, ASM500060, H3000WC and H3000WD. The device is used 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 Model Number 5178728: 17445 17001 17035 17023 17008 16988 17007 17010 17063 17077 17053 16995 17088 17098 17090 16990 17054 17099 17081 17060 17128 17140 17116 17004 17089 17036 17045 17129 17130 17108 17093 17171 17144 17158 17069 17135 17040 17172 17132 17183 17153 17201 17182 17111 17190 17187 17175 17169 17169 17169 17133 17213 17166 17104 17203 17141 17204 17139 17113 17224 17226 17228 17210 17229 17119 17255 17239 17233 17002 17266 17245 17276 17264 17248 17094 17256 17273 17254 17281 17294 17305 17277 17250 17252 17287 17307 17325 17285 17317 17288 17272 17299 17220 17321 17329 17341 17314 17293 17335 17328 17286 17366 17350 17306 17342 17096 17365 17309 17364 17349 17339 17369 17300 17390 17387 17361 17394 17376 17403 17359 17437 17415 17389 17382 17435 17423 17304 17449 17297 and 17241; Model Number ASM500060: 16821 16820 16846 16865 16852 16862 16880 16774 16893 16888 16874 16924 16928 16927 16933 16926 16937 16934 16938 16844 16930 16969 16962 16963 16977 16925 16901 16945 17005 16986 16914 17020 16944 16885 17034 17019 16949 17057 17055 17058 16976 16965 16976 17047 16987 and 17070; Model Number H3000WC: 16838 16849 16856 16850 16876 16869 16878 16811 16871 16889 16905 16898 16911 16921 16922 16910 16932 16886 16974 16955 16887 16919 16978 16968 16947 16979 16967 16972 16966 16970 17011 16994 17024 16950 17048 17042 17062 17018 17082 17105 17106 17000 17100 17125 17121 17025 17136 17122 17118 17041 17131 17103 17174 17164 17109 17197 17101 17114 16960 17199 17198 17124 17195 17179 17112 17185 17219 17238 17178 17247 17173 17265 16975 17259 17298 17260 17301 17278 17231 17165 17289 17290 17295 17333 17251 17338 17337 16946 17348 17373 17363 17347 17323 17326 17430 17416 17429 17415 17208 17422 17450 17258 and 17249; and Model Number HH3000WD: 17072 17126 17067 17067 17107 17163 17236 17346 and 17379.
Recalling Firm/
Manufacturer
GE Medical Systems, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer Reason
for Recall
The metal pin in the adjustable head holder, which is used to acquire Brain SPECT data on Infinia systems (Infinia, Infinia Hawkeye¿, and Infinia Hawkeye¿ 4), creates an artifact on the patient's cerebellum, which may lead to the potential for misdiagnosis.
FDA Determined
Cause 2
DESIGN: Labeling Design
Action Consignees were sent a GE "Product Safety Notification" letter dated April 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. Contact your local sales or service representative for further information regarding this notification by calling 1-800-437-1171 (within the US or Canada) and 1-262-896-2890 (outside the US).
Quantity in Commerce 122 US and 166 OUS
Distribution Worldwide Distribution -- USA (DC and Puerto Rico) including states of AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, and WI and countries of Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Czech, Denmark, Ecuador, Egypt, Finland, Finland, Egypt, Finland, France, Germany, Greece, Hungry, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Malaysia, Martinique, Mexico, Netherlands, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Republic of Georgia, Russia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, and 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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