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.
What this means for you
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.
- Hazard
- calculation-error
- image-offset-error
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:
- AL
- FL
- IA
- PA
- UT
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