Z-2297-2020 Class II Terminated
FDA device recall Z-2297-2020 was initiated by Elekta Limited on May 21, 2020 and is designated Class II. Reason for recall: 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 mo… The recall status is terminated (terminated August 19, 2024). Affected quantity: 26 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 17, 2020
- Initiation Date
- May 21, 2020
- Termination Date
- August 19, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26 units
Product Description
Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571
Reason for Recall
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.
Distribution Pattern
US distribution to IA, NY, PA, TX, WI. International distribution to Australia, Canada, China, Denmark, Germany, Hong Kong, Italy, Netherlands, Sweden, Switzerland, Turkey, United Kingdom.
Code Information
Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571. 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)