MOSAIQ, oncology information system - Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery.
This recall is currently active, issued March 26, 2020. It was issued by Elekta Impac Software.
- Company
- Elekta Impac Software
- Recall Initiated
- September 24, 2019
- Posted
- March 26, 2020
- Recall Number
- Z-1597-2020
- Quantity
- 3732 units
- Firm Location
- Sunnyvale, CA
- Official Source
- View on FDA website ↗
Reason for Recall
The user may inadvertently enter Metric values into Height and Weight fields labeled with US Standard Units.
Distribution
Worldwide distribution.
Lot / Code Info
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)
Root Cause
Software design
Action Taken
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.