FDA Medical Device Recalls (openFDA)
Elekta, Inc.: MOSAIQ Oncology Information System
- Recall number
- Z-2052-2016
- Recalling firm
- Elekta, Inc.
- Product
- MOSAIQ Oncology Information System
- Status
- Terminated
- Initiated
- 2016-06-17
- Posted
- not on file
- Terminated
- 2020-08-18
- Reason
- It is possible that that the selected Plan-of-the Day could be accidently changed by scrolling the mouse wheel up and down and inadvertently selecting another plan.
- Root cause
- Software design
- Action
- Elekta sent an Important Field Safety Notice to all customers on June 17, 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. A software patch will be issued for Mosaiq version 2.62 in order to the correct the defect. For further questions please call (404) 993-5886.
- Quantity
- 69
- Distribution
- US Distribution including Puerto Rico and to the states of : AK, AZ, CA, FL, GA, IL, IN, LA, MD, MI, MO, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and to the countries of : Canada, Denmark, Finland, Germany, Israel, Japan, Netherlands, Norway, Sweden, United Kingdom
- Lot, serial or model codes
- Versions 2.62 and higher
- 510(k) numbers
- ["K141572"]
- 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