Z-1783-2021 Class II Terminated
FDA device recall Z-1783-2021 was initiated by Elekta, Inc. on April 20, 2021 and is designated Class II. Reason for recall: Malware attack The recall status is terminated (terminated January 17, 2023). Affected quantity: 40 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 9, 2021
- Initiation Date
- April 20, 2021
- Termination Date
- January 17, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40 units
Product Description
Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 hosted on Classic Cloud
Reason for Recall
Malware attack
Distribution Pattern
Nationwide
Code Information
v2.62 - no UDI, v2.64 - 00858164002091, v2.70 - 00858164002237, v2.81 - 00858164002282, v2.82 - 00858164002336, v2.83 - 00858164002367