Company:Nucletron BV
Date of Enforcement Report 11/1/2017
Class lI:
PRODUCT
Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.
Recall Number Z-0050-2018
REASON
Incorrect source step size may occur in the software plans.
RECALLING FIRM/MANUFACTURER
Nucletron BV, Veenendaal, Netherlands on 8/10/2017. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
89 customer sites have the affected software
DISTRIBUTION
Nationwide and Internationally
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