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

Recall Z-1238-2015 — Elekta Precise Treatment Table

U.S. FDA — Device Enforcement · United States · 2015-01-29 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1238-2015
Date of alert
2015-01-29
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Elekta, Inc.
Product category
device
Product type
Devices
Reported risk: It is possible to position the Treatment Table with errors greater than 5mm and no inhibits are displayed, if the positional sensors are not correctly installed during corrective maintenance. Clinical mistreatment may occur if a position error is not detected.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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