FDA Device recall Z-0821-2019
MOSAIQ¿ Oncology Information System and Sequencer MOSAIQ is an oncology information system used to manage workflows for treatment planning…
- FDA Device
- Class II
- ongoing
- Published 2019-02-20
On 2019-02-20 the FDA classified a Class II recall of MOSAIQ¿ Oncology Information System and Sequencer MOSAIQ is an oncology information system used to manage workflows for treatment planning… by Elekta, citing 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 fiel….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0821-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2018-12-13 |
| Published | 2019-02-20 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Elekta |
| Distribution | US |
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.
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.
Identifiers
| code_info | MOSAIQ Radiation Oncology version 1.0 and higher. Multi-ACCESS version 6.1 and higher. UDI 858164002084 8581640…MOSAIQ Radiation Oncology version 1.0 and higher. Multi-ACCESS version 6.1 and higher. UDI 858164002084 858164002091 858164002107 858164002220 858164002237 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Other recalls by Elekta
- Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading Applicator Product Description: The Flet…
FDA Device · Class II · 2026-07-15 · Elekta - Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Product Description: The intended use of the Advanced…
FDA Device · Class II · 2026-07-15 · Elekta - Brand Name: Geneva Product Name: Brachytherapy Applicator Product Description: The device is intended for intracavitary brachytherapy for c…
FDA Device · Class II · 2026-07-15 · Elekta - MOSAIQ Oncology Information System
FDA Device · Class II · 2026-06-17 · Elekta - Brand Name: Leksell Vantage Arc System REF: 1053958
FDA Device · Class II · 2026-05-06 · Elekta
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0821-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.