FDA Medical Device Recalls (openFDA)
Elekta, Inc.: MOSAIQ Oncology Information System
- Recall number
- Z-2591-2021
- Recalling firm
- Elekta, Inc.
- Product
- MOSAIQ Oncology Information System
- Status
- Open, Classified
- Initiated
- 2021-09-02
- Posted
- not on file
- Terminated
- not on file
- Reason
- A drug strength in MOSAIQ can be changed during the ordering process and approved, but the saved drug strength reverts to the original value.
- Root cause
- Software design
- Action
- The recalling firm issued an "URGENT IMPORTANT FIELD SAFETY NOTIFICATION" dated August 2021 via email to its consignees on 9/2/2021. Recommendations were made to the user until a fix is available.
- Quantity
- 31
- Distribution
- Distribution was made to CA, CO, FL, ID, LA, MO, MS, NC, NH, NM, NV, NY, OH, OK, PA, SD, and WA. There was no military/government distribution. Foreign distribution was made to Australia, Canada, and the United Kingdom.
- Lot, serial or model codes
- MOSAIQ 2.83 when run with First Data Bank (FDB), UDI/GTIN MOSAIQ 2.83 (0858164002367)
- 510(k) numbers
- ["K183034"]
- PMA numbers
- not on file
- Product code
- IYE
- 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