Recalls / —
—#187549
Product
Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 hosted on Classic Cloud
- FDA product code
- IYE — Accelerator, Linear, Medical
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K141572, K183034
- Affected lot / code info
- v2.62 - no UDI, v2.64 - 00858164002091, v2.70 - 00858164002237, v2.81 - 00858164002282, v2.82 - 00858164002336, v2.83 - 00858164002367
Why it was recalled
Malware attack
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
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.
Recalling firm
- Firm
- Elekta, Inc.
- Address
- 400 Perimeter Center Ter NE, Ste 50, Atlanta, Georgia 30346-1227
Distribution
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2021-04-20
- Terminated
- 2023-01-17
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #187549. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.