Z-2406-2026Class II

MOSAIQ Oncology Information System

Name: Z-2406-2026 MOSAIQ Oncology Information System
Creator: Elekta, Inc.
Published: 2026-05-21
License: https://open.fda.gov/license/

Elekta Limited / initiated 2026-05-21 / Open, Classified / root cause: software

FDA source

Elekta, Inc. began a recall of MOSAIQ Oncology Information System on 2026-05-21. FDA classified it as Class II and gives the reason as "Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs". 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-2406-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-21
Posted: 2026-06-11
Recalling firm: Elekta Limited
Product: MOSAIQ Oncology Information System
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
Root cause tag: software
FDA root cause: Software design
Action: On May 21, 2026, Elekta issued a "Urgent Medical Device Notification to affected to consignees via E-Mail. Elekta asked consignees to take the following actions: 1. Please review this notification and identify if you are running the effected software version listed above. 2. If an Application Communication Time Out error message appears during a BLS plan transfer, please refer to the attached appendix. 3. Please acknowledge receipt of this notification via the Elekta Care Community or complete this form and return it to Elekta immediately upon receipt, but no later than within 30 days. 4. Please post this notice in a place accessible to all users, e.g. Instructions for Use, until this action is closed. 5. Advise the appropriate personnel working with this product of the content of this letter. 6. If affected product has been transferred to a different location, please ensure that location and personnel receive a copy of this notification.
Quantity in commerce: 12 programs
Distribution: Worldwide - US Nationwide distribution in the states of WI, FL, LA, NY, NY, NJ, KS, FL, IA, NM, TX and the countries of Bahrain, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, India, Israel, Italy, Japan, Lithuania, Malta, Mexico, Netherlands, Pakistan, Panama, Poland, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom.
Product codes and lots: Software Version: MOSAIQ 3.2/UDI: 07340201500071

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2406-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2406-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-17	2026-06-11

Product code IYE

K223229Class IIMOSAIQ® OIS (Oncology Information System)Elekta Solutions AB / cleared 2023-02-23

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)