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Recall Observatory FDA recall evidence

Device product

Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 hosted on Classic Cloud

Z-1783-2021

April 20, 2021

Class II

Product summary

Firm
Elekta, Inc.
Event
Event 87965
Status
Terminated
Classification
Class II
Quantity
40 units
Official record key
device-enforcement:Z-1783-2021

Official wording

Reason: Malware attack

Code information: v2.62 - no UDI, v2.64 - 00858164002091, v2.70 - 00858164002237, v2.81 - 00858164002282, v2.82 - 00858164002336, v2.83 - 00858164002367

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Malware attack