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

Recall Z-1966-2015 — GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic Systems. A universal diagnostic imaging system for radiographic and fluoroscopic examinations. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Le

U.S. FDA — Device Enforcement · United States · 2015-06-12 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1966-2015
Date of alert: 2015-06-12
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: GE Healthcare
Product category: device
Product type: Devices

Reported risk: The SFD/IDD safety mechanism may not engage properly at the lower range of SFD/IDD travel. This mechanism is installed to hold and prevent the SFD/IDD from falling due to a counterweight cable failure. The lower range of travel is 1.1 in (28mm) from the lowest point of normal SFD/IDD vertical compression. A fall of the SFD/IDD could result in an injury to a patient or operator.

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

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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