Company: Elekta, Inc.
Date of Enforcement Report: 2/8/2019
Class II:
PRODUCT
MOSAIQ Oncology Information System and Sequencer MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
Recall Number: Z-0821-2019
REASON
There is a potential that Wedge IDs were not included in the DICOM RT PLAN sent from the TPS, which will cause the field in MOSAIQ to be created with no wedge. Treatment of a field without the planned wedge will receive more dose than the treatment plan indicates.
RECALLING FIRM/MANUFACTURER
Elekta, Inc. on 12/13/2018. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
3,950 units total (1,747 US)
DISTRIBUTION
US Nationwide