Recall Z-2297-2020 ยท IYE Accelerator, Linear, Medical
Elekta Limited
Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571
| Date | Jun 8, 2020 (initiated May 21, 2020) |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | Elekta notified customers of the recalls on about 05/21/2020 via "URGENT IMPORTANT FIELD SAFETY NOTIFICATION" letter. Customers were informed that 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. Instructions included that although there is no method to correct the scaling issue for the affected protocols, the device can still be used under two options: 1. Without the use of Motion Monitoring and 2. compensation for intr |
| Quantity | 26 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192482 | Elekta Unity Elekta Limited, Dec 5, 2019 |