Reported Jun 17, 2020 · Terminated
Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571
Elekta Limited
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Elekta Limited · Linac House · Crawley, N/A · N/A
Is this the product you have?
- Elekta Unity
- Philips Marlin Software versions
R5.3.30R5.3.31R6.0.5331R5.7.0R5.7.1R6.1.571
- Lot codes and dates
- Software versions
R5.3.30R5.3.31R6.0.5331R5.7.0R5.7.1R6.1.571. UDI Number 05060191071321
- Anatomy (Protocol Name)Abdomen (btFFE Cor RealTime, 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, bFFE Cor Sag RealTime, bFFE Cor Sag Tra RealTime, bFFE Sag RealTime, bFFE Sag Tra RealTime); Pelvis L (bFFE Cor RealTime, bFFE Cor Sag RealTime, bFFE Cor Sag Tra RealTime, bFFE Sag RealTime, bFFE Sag Tra RealTime); Pelvis M (bFFE Cor RealTime, bFFE Cor Sag RealTime, bFFE Cor Sag Tra RealTime, bFFE Sag RealTime, bFFE Sag Tra RealTime); Thorax (btFFE Cor RealTime, btFFE Cor Sag RealTime, btFFE Cor Sag Tra RealTime, btFFE Sag RealTime, btFFE Sag RealTime)
- Software versions
- Amount recalled
- 26 units
Where it was sold
Why it was recalled
In TSM (Treatment Session Manager) Motion Monitoring workflows, under certain conditions there can be a mismatch between the contour data overlay with respect to the motion monitoring images of the monitored structure.
This product could cause temporary or reversible health problems — stop using it.
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