Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1199-2014 — GE Healthcare Varicam/VG and VG Hawkeye 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 typed and

U.S. FDA — Device Enforcement · United States · 2014-02-07 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1199-2014
Date of alert: 2014-02-07
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: GE Healthcare, LLC
Product category: device
Product type: Devices

Reported risk: 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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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