Recall Z-2297-2020— Elekta Limited
Class II · Terminated
Class II FDA medical device recall by Elekta Limited, initiated 2020-05-21, terminated 2024-08-19. It names one FDA 510(k) clearance: K192482. 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. Reason: 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..
- Recalling firm
- Elekta Limited
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-05-21
- Terminated
- 2024-08-19
- Firm location
- Crawley, N/A, United Kingdom
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.