Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 hosted on Classic Cloud
FDA Recall Z-1783-2021 · Posted None
Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeIYE
Date Initiated2021-04-20
Date Terminated2023-01-17
Product Quantity40 units
Reason for Recall
Malware attack
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.
Root Cause
Under Investigation by firm
Distribution Pattern
Nationwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.