Device product
There is a complaint regarding internal check cable guide mechanism failure for the Nucletron Flexitron brachytherapy afterloader system. Due to an obstruction during the check cable out drive, the internal guiding tube became displaced and the check cable became damaged. This issue could cause treatment interruption or in a very unlikely scenario, incorrect source positioning and radiation treatment errors.
Z-0772-2020
Product summary
- Firm
- Nucletron BV
- Event
- Event 84371
- Status
- Terminated
- Classification
- Class II
- Quantity
- 383
- Official record key
device-enforcement:Z-0772-2020
Official wording
Reason: A component failure may lead to treatment interruption or incorrect source positioning.
Code information: REF 136149A02; UDI: (01)08717213051126 (11)171127 (21)FT00340 (240)136149
Distribution pattern: Distribution in United States and worldwide
Derived failure modes
-
Unknown
A component failure may lead to treatment interruption or incorrect source positioning.