FDA Enforcement
Class II
Terminated
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.
Recall: Z-0772-2020
·
Reported January 8, 2020
Enforcement
- Recall Number
- Z-0772-2020
- Event ID
- 84371
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Nucletron BV
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 8, 2020
- Initiation Date
- November 18, 2019
- Classification Date
- January 2, 2020
- Termination Date
- March 28, 2023
- Address
- Waardgelder 1, POBox 930, Veenendaal, N/A, N/A, Netherlands
Description
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.
Reason
A component failure may lead to treatment interruption or incorrect source positioning.
Code Info
REF 136149A02; UDI: (01)08717213051126 (11)171127 (21)FT00340 (240)136149
Distribution
Distribution in United States and worldwide
Quantity
383