Elekta Unity Software Recall for Motion Monitoring Data Mismatch
Elekta Limited is recalling specific Unity software versions due to a potential mismatch between contour data and motion monitoring images.
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: The recall is classified as FDA Class II and involves a risk-of-harm product (medical device software) where the hazard is a data mismatch, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Elekta Limited is recalling specific versions of Elekta Unity and Philips Marlin software (R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, and R6.1.571). The recall involves 26 units distributed in the United States to Iowa, New York, Pennsylvania, Texas, and Wisconsin, as well as internationally to Australia, Canada, China, Denmark, Germany, Hong Kong, Italy, the Netherlands, Sweden, Switzerland, Turkey, and the United Kingdom.
The recall was initiated because, in Treatment Session Manager (TSM) Motion Monitoring workflows, there can be a mismatch between the contour data overlay and the motion monitoring images of the monitored structure under certain conditions. This issue affects specific anatomy protocols including Abdomen, HeadNeck L, HeadNeck M, Pelvis L, Pelvis M, and Thorax.
The FDA has classified this as a Class II recall. Users of the affected software should contact Elekta Limited for further instructions on how to resolve the issue.
The recalled product
- Product
- Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571
- Manufacturer
- Elekta Limited
- Affected units
- 26
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 (19)
- Software versions: R5.3.30
- R5.3.31
- R6.0.5331
- R5.7.0
- R5.7.1
- btFFE Cor Sag RealTime
- btFFE Cor Sag Tra RealTime
- btFFE Fast Sag Cor RealTime
- btFFE Sag RealTime)
- HeadNeck L (bFFE Cor RealTime
- bFFE Cor Sag RealTime
- bFFE Cor Sag Tra RealTime
- bFFE Sag RealTime
- bFFE Sag Tra RealTime)
- HeadNeck M (bFFE Cor RealTime
- Pelvis L (bFFE Cor RealTime
- Pelvis M (bFFE Cor RealTime
- Thorax (btFFE Cor RealTime
- btFFE Sag RealTime
Distribution
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