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

Recall Z-0957-2015 — iPlan RT is a radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.

U.S. FDA — Device Enforcement · Germany · 2014-11-19 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0957-2015
Date of alert
2014-11-19
Country / jurisdiction
Germany
Risk level
Class II
Risk type
recall
Brand
Brainlab AG
Product category
device
Product type
Devices
Reported risk: iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when using multiple localized CT image data sets.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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