ClearanceBrief
Recall Z-1783-2021 ยท IYE Accelerator, Linear, Medical

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

DateApr 20, 2021
StatusTerminated
ReasonMalware attack
Root causeUnder Investigation by firm
ActionThe 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.
Quantity40 units
DistributionNationwide
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K141572MOSAIQ ONCOLOGY INFORMATION SYSTEM
Impac Medical Systems, Inc., Sep 5, 2014
K183034MOSAIQ Oncology Information System
Elekta, Inc., Dec 4, 2018