Recall Z-1162-2025— Elekta, Inc.

Name: FDA recall Z-1162-2025
Creator: U.S. Food and Drug Administration
Published: 2025-01-15

Class II · Ongoing

Class II FDA medical device recall by Elekta, Inc., initiated 2025-01-15. It names one FDA 510(k) clearance: K223229. Product: MOSAIQ Oncology Information System. Reason: Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-01-15
Firm location: Atlanta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K223229 — MOSAIQ® OIS (Oncology Information System)Elekta Solutions AB·cleared 2023-02-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

MOSAIQ Oncology Information System

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.