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U.S. Department of Health and Human Services

Class 1 Device Recall Infinia

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  Class 1 Device Recall Infinia see related information
Date Initiated by Firm June 13, 2013
Date Posted July 24, 2013
Recall Status1 Terminated 3 on June 19, 2014
Recall Number Z-1787-2013
Recall Event ID 65579
510(K)Number K052434  K991841  K022960  
Product Classification System, tomography, computed, emission - Product Code KPS
Product GE Healthcare Infinia Hawkeye 4 Option For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera (this includes GE Quasar Nuclear Medicine Systems). Nuclear Medicine Systems Infinia devices

Product Usage: The intended use of the Quasar system is 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 System ID: 1153389, 1299296, 2555007, 2621801, 2638808, 2694593, 2760723, 2768147, 2769200, 2775945, 2812777, 2827087, 2883051, 0828260003, 0828260005, 0828260006, 0828260007, 0828260009, 0828260011, 0828260013, 0828260015, 0828260017, 0828260018, 0828260019, 0828260020, 0834260003, 0834260008, 0834260012, 835260007, 0835260010, 0835260013, 0843260029, 0843260032, 0843260034, 0843260037, 0843260044, 0843260047, 0843260048, 0847260025, 0850260060, 0850260061, 0850260063, 0850260064, 0850260065, 0850260066, 0850260067, 0850260068, 0850260069, 0850260070, 0850260073, 0850260074, 0850260075, 0850260076, 0850260077, 0850260079, 0850260080, 0850260081, 0850260082, 0850260083, 0850260084, 0850260087, 0850260088, 0850260089, 0850260090, 0850260091, 0850260092, 0850260093, 0850260094, 0850260095, 0850260096, 0850260098, 0850260099, 0850260100, 0850260103, 0850260104, 0850260105, 0850260106, 0850260107, 0850260108, 0850260109, 0850260110, 0850260111, 0850260112, 0850260113, 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Recalling Firm/
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact technical services
Manufacturer Reason
for Recall
GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System.
FDA Determined
Cause 2
Device Design
Action GE sent an Urgent Medical Device Correction letter dated June 17, 2013 to all affected customers. The letter identified the affected product, recommended that qualified service personnel maintain the equipment and that Preventative Maintenance procedures are executed according to labeling. Also the Safety Chapter Sections should be re-reviewed with personnel to ensure proper operation of the equipment. GE notified customers again on July 03, 2013, via Urgent Medical Device Recall letter (including confirmation of delivery for US customers) and follow-up telephone call. Customers were instructed to cease using the affected system until GE Healthcare Field Engineer can complete an inspection of the system and perform any necessary repairs at no cost. A GE Healthcare representative will contact the hospitals to arrange for the inspection.
Quantity in Commerce 2474
Distribution Worldwide Distribution - US Nationwide including Guam, Puerto Rico and the countries of : Afghanistan, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea (Republic of), Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Malta, Martinique, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, Venezuela, Vietnam.
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
510(K)s with Product Code = KPS and Original Applicant = GE MEDICAL SYSTEMS F.I. HAIFA