FDA Medical Device Recalls (openFDA)
Elekta, Inc.: Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 hosted on Classic Cloud
- Recall number
- Z-1783-2021
- Recalling firm
- Elekta, Inc.
- Product
- Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 hosted on Classic Cloud
- Status
- Terminated
- Initiated
- 2021-04-20
- Posted
- not on file
- Terminated
- 2023-01-17
- Reason
- Malware attack
- Root cause
- Under Investigation by firm
- Action
- The firm notified the users by telephone on 04/20/2021 and followed with a written notice disseminated by email on 04/22/2021. For questions contact your Elekta Representative.
- Quantity
- 40 units
- Distribution
- Nationwide
- Lot, serial or model codes
- v2.62 - no UDI, v2.64 - 00858164002091, v2.70 - 00858164002237, v2.81 - 00858164002282, v2.82 - 00858164002336, v2.83 - 00858164002367
- 510(k) numbers
- ["K141572","K183034"]
- 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