FDA Medical Device Recalls (openFDA)
Elekta Impac Software: MOSAIQ, oncology information system - Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery.
- Recall number
- Z-1597-2020
- Recalling firm
- Elekta Impac Software
- Product
- MOSAIQ, oncology information system - Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery.
- Status
- Open, Classified
- Initiated
- 2019-09-24
- Posted
- 2020-03-26
- Terminated
- not on file
- Reason
- The user may inadvertently enter Metric values into Height and Weight fields labeled with US Standard Units.
- Root cause
- Software design
- Action
- 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.
- Quantity
- 3732 units
- Distribution
- Worldwide distribution.
- Lot, serial or model codes
- 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)
- 510(k) numbers
- ["K141572"]
- PMA numbers
- not on file
- Product code
- MUJ
- Firm FEI
- 1000123805
- Firm city
- Sunnyvale
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28