GE Healthcare, LLC Recall: Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digita
GE Healthcare, LLC Recall: Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digita is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: GE Healthcare, LLC; Product: Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product Usage: The intended use of the Q
| Recalling firm | GE Healthcare, LLC |
|---|---|
| Product | Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera 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 typed and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT, Gated SPECT, |
| 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. N |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | 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, Ger |
| Recall initiated | 20140207 |
| Recall number | Z-1200-2014 |
| Category | device |
| State | WI |
| Country | United States |
$29/mo
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