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

Recall Z-0080-2017 — Zero-Gravity Radiation Protection System Radiology Personnel protective shield.

U.S. FDA — Device Enforcement · United States · 2016-09-09 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0080-2017
Date of alert
2016-09-09
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Contour Fabricators Inc
Product category
device
Product type
Devices
Reported risk: Two customer complaints suggest that excessive rotation of the cable in one direction (clockwise or counter-clockwise) without allowing the cable to unwind to its normal condition may cause the cable to break suddenly and the body shield to fall. While no injuries or deaths occurred in either failure, the Zero-GravityTM body shield weighs 55 pounds, and in the event of a cable failure, the body shield will fall immediately. A fall of this nature places the user, associated staff and the patient at risk for a potential injury.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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