Class 2 Device Recall MOSAIQ

• Date Initiated by Firm: April 20, 2021
• Create Date: June 02, 2021
• Recall Status: Terminated on January 17, 2023
• Recall Number: Z-1783-2021
• Recall Event ID: 87965
• 510(K)Number: K141572 K183034
• Product Classification: Accelerator, linear, medical - Product Code IYE
• Product: Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 hosted on Classic Cloud
• Code Information: v2.62 - no UDI, v2.64 - 00858164002091, v2.70 - 00858164002237, v2.81 - 00858164002282, v2.82 - 00858164002336, v2.83 - 00858164002367
• Recalling Firm/ Manufacturer: Elekta, Inc.; 400 Perimeter Center Ter NE Ste 50; Atlanta GA 30346-1227
• For Additional Information Contact: 770-670-2422
• Manufacturer Reason for Recall: Malware attack
• FDA Determined 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 in Commerce: 40 units
• Distribution: Nationwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = IYE; 510(K)s with Product Code = IYE