Company:Elekta Inc.
Date of Enforcement Report: 11/4/2015
Class lI:
PRODUCT
Monaco – Radiation Treatment Planning used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Recall Number Z-0181-2016
REASON
Unintended update of Dose and MU and Incorrect Assignment of Bolus.
RECALLING FIRM/MANUFACTURER
Elekta Inc., Atlanta, GA on 10/16/2015 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
154
DISTRIBUTION
CA, IN, MI,MO, TX, WI, Australia, Canada, Germany,m Greece, India, Netherlands, New Zealand, Turkey and United Kingdom
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