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

Recall Z-1441-2015 — Kenex Radiation Shield installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems.

U.S. FDA — Device Enforcement · United States · 2015-03-09 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1441-2015
Date of alert
2015-03-09
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
GE Healthcare
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00000609
Reported risk: GE Healthcare has recently become aware of an improper installation of a ceiling suspended pendent supporting a radiation shield and/or surgical lamp. The pendent system was not installed per specified installation requirements. There has been a reported incident of a radiation shield falling from the ceiling causing a minor injury.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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