Z-1783-2021Class II

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

Name: Z-1783-2021 Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 hosted on Classic...
Creator: Elekta, Inc.
Published: 2021-04-20
License: https://open.fda.gov/license/

Elekta Limited / initiated 2021-04-20 / Terminated

FDA source

Elekta, Inc. began a recall of Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 hosted on Classic Cloud on 2021-04-20. FDA classified it as Class II and gives the reason as "Malware attack". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1783-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-20
Posted: 2021-06-02
Terminated: 2023-01-17
Recalling firm: Elekta Limited
Product: Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 hosted on Classic Cloud
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Malware attack
FDA root 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
Product codes and lots: v2.62 - no UDI, v2.64 - 00858164002091, v2.70 - 00858164002237, v2.81 - 00858164002282, v2.82 - 00858164002336, v2.83 - 00858164002367

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1783-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1783-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-02

Product code IYE

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)