—#212143

Product

MOSAIQ Oncology Information System

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K223229
Affected lot / code info: 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

Why it was recalled

Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Elekta, Inc.
Address: 400 Perimeter Center Ter NE, Ste 50, Atlanta, Georgia 30346-1227

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2025-01-15
Posted by FDA: 2025-02-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #212143. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.