Company: Elekta Inc.
Date of Enforcement Report: 10/6/2021
Class II
PRODUCT
Elekta Monaco – Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Recall Number: Z-2563-2021
REASON
Contour changes can be saved on an unintended image set. In addition, these contour edits do not cause the dose to be frozen on the plans associated with that image set.
RECALLING FIRM/MANUFACTURER
Elekta Inc. on 9/14/2021. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
214 units
DISTRIBUTION
U.S. Nationwide and International