FDA Medical Device Recalls (openFDA)
Elekta, Inc.: MOSAIQ Oncology Information System
- Recall number
- Z-2293-2016
- Recalling firm
- Elekta, Inc.
- Product
- MOSAIQ Oncology Information System
- Status
- Open, Classified
- Initiated
- 2016-07-15
- Posted
- not on file
- Terminated
- not on file
- Reason
- It is possible that a change to an Order Set will not be saved in the current open Care Plan. This can result in a wrong chemo dose in the order.
- Root cause
- Software Design Change
- Action
- Elekta sent Important Field Safety Notice 371-03-MSQ-001 to all customers on 7/15/2016. The notice informs users of the specific product and version numbers affected by the issue, and any work around that can be used to avoid the issue. The letter also included a response form which is to be returned to Elekta.
- Quantity
- 383
- Distribution
- Worldwide distribution. US nationwide, Antigua and Barbuda, Australia, Austria, Bahamas, Bahrain, Canada, Czech Republic, Germany, Hungary, South Africa, Spain, Sweden, Turkey, and United Kingdom
- Lot, serial or model codes
- Versions 2.50.05 and higher
- 510(k) numbers
- ["K123230"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 1037831
- Firm city
- Atlanta
- Firm state
- GA
- 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