Data Foundry

Medical device recalls 2021

Elekta MOSAIC Oncology Information System versions: 2 — Class II medical device recall Z-1783-2021

Terminated recall by Elekta, Inc., reported 2021-06-09, distributed nationwide. Malware attack

Recall numberZ-1783-2021
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmElekta, Inc., Atlanta, GA, United States
Recall initiated2021-04-20
Classified2021-06-02
Reported by FDA2021-06-09
Terminated2023-01-17
DistributedNationwide (US)
Quantity40 units
UPC / GTIN / UDI-DI00858164002091, 00858164002237, 00858164002282, 00858164002336, 00858164002367

Product

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1783-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.