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U.S. Department of Health and Human Services

Enforcement Report - Week of March 19, 2014

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Product Description GE Healthcare Infinia and Infinia Hawkeye Nuclear Medicine Systems. 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.
Recall Number Z-1198-2014
Classification Class II
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000003100-1829, 000003100-1838, 000003100-1840, 000003101-1502, 000003651-4185, 000003681-1803, 000003818-1210, 000003818-1224, 000003818-4187, 000008125-1630, 00000I92S08001, 00000ICPO50612, 00003618-12-26, 00003652-41-95, 00003817-11-12, 00003817-11-69, 00003818-11-41, 00003818-11-47, 00003818-11-82, 00003818-12-19, 00003818-32-02, 00008125-16-25, 00008125-16-70, 00008125-16-88, 00008125-16-89, 00008125-18-09, 00008125-18-10, 00008125-18-16, 00008125-18-18, 0000D4360X4372, 0003811-81-231, DUMFMI40849005, DUMFMI40849009, DUMFMI40849010, DUMFMI40849011, DUMFMI40849012, DUMFMI40849013, DUMFMI40849014, DUMFMI40849015, DUMFMI40849016, DUMFMI40849017, DUMFMI40849018, DUMFMI40849019, DUMFMI40849020, DUMFMI40849023, DUMFMI40849026, UNKASM00109200, UNKASM00109201, UNKASM00109204, UNKELS00000372.
Product Distributed Qty 3062 units (1182 US, 1880 OUS)
Reason For Recall Potential safety issue related to unintended radial detector motion, which may occur during patient setup or at the end of a patient scan. This failure mode has been observed on a single system, in which the detector moved to the home position and then slowly starting drifting inward toward the patient. This generated both a visual and audio alert condition on both the console and the gantry. No injuries have been reported.

Event Detail

Event Id 67464
Product Type Devices
Status Ongoing
Recalling Firm GE Healthcare, LLC
City Waukesha
State WI
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-02-07
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution-USA (nationwide) including Puerto Rico and Guam and the countries of 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, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, and United Kingdom.
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