MOSAIQ, oncology information system - Product Usage: MOSAIQ… recallZ-1597-2020 · Elekta Impac Software · initiated Sep 24, 2019
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Elekta Impac Software or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The user may inadvertently enter Metric values into Height and Weight fields labeled with US Standard Units.
FDA root cause category: Software design
What the company is doing
The firm began notifying their consignee on 09/24/2019 by email. The notice explained the issue and provided a workaround for the consignee to use until the updated software is ready for release.
Recall details
- Recall number
- Z-1597-2020
- Status
- Open, Classified
- Initiated by the company
- Sep 24, 2019
- Posted by the FDA
- Mar 26, 2020
- Recalling firm
- Elekta Impac Software
- Quantity
- 3732 units
- Product code
- MUJ
- FDA submissions
- K141572
- Distribution
- Worldwide distribution.
Product description
MOSAIQ, oncology information system - Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery.
Code information (models, lots, serial numbers)
Software Versions (UDI/GTIN): MOSAIQ 2.00 (00858164002305); MOSAIQ 2.20 (00858164002312); MOSAIQ 2.30 (00858164002329); MOSAIQ 2.40 (00858164002077); MOSAIQ 2.41 (00858164002084); MOSAIQ 2.60 -2.64 (00858164002091); MOSAIQ 2.50 (00858164002107); MOSAIQ 2.65 (00858164002220); MOSAIQ 2.70 (00858164002037); MOSAIQ 2.80 (00858164002251); MOSAIQ 2.81 (00858164002282)
Devices named in this recall
4 devices in the FDA device registry whose identifier appears in the recall's code information.
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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