Company: Elekta, Inc.
Date of Enforcement Report 10/19/2016
Class lI:
PRODUCT
Monaco RTP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon treatment plans and displays, on-screen and in hard-copy, two or three dimensional radiation dose distribution inside patients for given treatment plan set-ups
Recall Number Z-0076-2016
REASON
PWhen creating 3D plans using either MU or Dose weighting modes, if the user changes the Physician’s Intent Rx Dose and/or the number of fractions, and then modifies the wedge angle, the MU value is scaled incorrectly..
RECALLING FIRM/MANUFACTURER
Elekta inc., Atlanta, GA on 10/13/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
365
DISTRIBUTION
Nationwide and Internationally
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