The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1162-2025·Announced 2025-02-19

Elekta MOSAIQ Oncology Information System: Incorrect Image Offset Calculations

Elekta is recalling MOSAIQ Oncology Information System software that may produce incorrect image offsets for Linear Accelerators not characterized at IEC61217 scale.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device software error affecting radiation therapy systems. The potential for incorrect image offset calculations in cancer treatment represents a high-risk scenario. No reported injuries or illnesses are mentioned, classifying this as a risk-of-harm product without reported injury.

Plain-English summary

Elekta, Inc. is recalling the MOSAIQ Oncology Information System software due to image offsets calculated by the software that may be incorrect for Linear Accelerators (LINACs) not characterized according to the IEC61217 standard.

Affected software versions include 3.1.2.0 through 3.1.3.4 and 3.2.1.0 through 3.2.1.4. A total of 64 units are affected. The software has been distributed in the United States (Pennsylvania, Alabama, Florida, Iowa, and Utah) and internationally in Austria, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Canada, France, Germany, Hong Kong, Italy, Japan, Korea, Malta, Netherlands, Panama, South Africa, Spain, Taiwan, Thailand, Turkey, and Venezuela.

The recalled product

Product
MOSAIQ Oncology Information System
Manufacturer
Elekta, Inc.
Category
Medical Device — Oncology Information System
Hazard
Affected units
64

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (10)

  • 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

Distribution

Distributed in 5 states:

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