Z-1162-2025Class II

MOSAIQ Oncology Information System

Name: Z-1162-2025 MOSAIQ Oncology Information System
Creator: Elekta, Inc.
Published: 2025-01-15
License: https://open.fda.gov/license/

Elekta Limited / initiated 2025-01-15 / Open, Classified / root cause: software

FDA source

Elekta, Inc. began a recall of MOSAIQ Oncology Information System on 2025-01-15. FDA classified it as Class II and gives the reason as "Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale". 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-1162-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-01-15
Posted: 2025-02-12
Recalling firm: Elekta Limited
Product: MOSAIQ Oncology Information System
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.
Root cause tag: software
FDA root cause: Software design
Action: On January 15, 2025 Elekta issued a recall notification to affected consignees via Email. Elekta asked consignees to take the following actions. 1. Customers included in the scope of the Field Safety Notice, should not calculate shifts from 2D verification images taken at a non-zero patient support angle (couch angle). 2. Please post this notice in a place accessible to all users, e.g. Instructions for Use, until this action is closed. 3. Advise the appropriate personnel, working with this product, on the content of this letter. 4. You are required to either 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.
Quantity in commerce: 64 units
Distribution: US: PA, AL, FL, IA UT OUS: Austria Belgium Bolivia Bosnia and Herzegowina Brazil Canada France Germany Hong Kong Italy Japan Korea, Republic of Malta Netherlands Panama South Africa Spain Taiwan Thailand Turkey Venezuela
Product codes and lots: Software versions /UDI: 3.1.2.0 (01)07340201500026 3.1.3.0 (01)07340201500026; 3.1.3.1 (01)07340201500026; 3.1.3.2 (01)07340201500026; 3.1.3.3 (01)07340201500026; 3.1.3.4 (01)07340201500026; 3.2.1.0 (01)07340201500071; 3.2.1.1 (01)07340201500071; 3.2.1.2 (01)07340201500071; 3.2.1.3 (01)07340201500071; 3.2.1.4 (01)07340201500071

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1162-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1162-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-19	2025-02-11

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)