Z-2591-2021Class II

MOSAIQ Oncology Information System

Name: Z-2591-2021 MOSAIQ Oncology Information System
Creator: Elekta, Inc.
Published: 2021-09-02
License: https://open.fda.gov/license/

Elekta Limited / initiated 2021-09-02 / Open, Classified / root cause: software

FDA source

Elekta, Inc. began a recall of MOSAIQ Oncology Information System on 2021-09-02. FDA classified it as Class II and gives the reason as "A drug strength in MOSAIQ can be changed during the ordering process and approved, but the saved drug strength reverts to the original value". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2591-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-09-02
Posted: 2021-09-29
Recalling firm: Elekta Limited
Product: MOSAIQ Oncology Information System
Product code: IYE Accelerator, Linear, Medical
Reason for recall: A drug strength in MOSAIQ can be changed during the ordering process and approved, but the saved drug strength reverts to the original value.
Root cause tag: software
FDA root cause: Software design
Action: The recalling firm issued an "URGENT IMPORTANT FIELD SAFETY NOTIFICATION" dated August 2021 via email to its consignees on 9/2/2021. Recommendations were made to the user until a fix is available.
Quantity in commerce: 31
Distribution: Distribution was made to CA, CO, FL, ID, LA, MO, MS, NC, NH, NM, NV, NY, OH, OK, PA, SD, and WA. There was no military/government distribution. Foreign distribution was made to Australia, Canada, and the United Kingdom.
Product codes and lots: MOSAIQ 2.83 when run with First Data Bank (FDB), UDI/GTIN MOSAIQ 2.83 (0858164002367)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2591-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2591-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-10-06	2021-09-29

Product code IYE

K183034Class IIMOSAIQ Oncology Information SystemElekta, Inc. / cleared 2018-12-04

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)