Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0821-2019 — 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.

U.S. FDA — Device Enforcement · United States · 2018-12-13 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0821-2019
Date of alert
2018-12-13
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Elekta, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
858164002084
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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