Company:Brainlab AG
Date of Enforcement Report: 1/21/2015
Class lI:
PRODUCT
Plan RT Dose is a stereotactic 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.
Recall Number Z-0956-2015
REASON
iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when using multiple localized CT image data sets..
RECALLING FIRM/MANUFACTURER
Brainlab AG, Feldkirchen, DE on 11/19/2014 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
1,412 systems total
DISTRIBUTION
Nationwide and Internationally
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