Recall Z-0772-2020— Nucletron BV
Class II · Terminated
Class II FDA medical device recall by Nucletron BV, initiated 2019-11-18, terminated 2023-03-28. It names one FDA 510(k) clearance: K070574. 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.. Reason: A component failure may lead to treatment interruption or incorrect source positioning..
- Recalling firm
- Nucletron BV
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-11-18
- Terminated
- 2023-03-28
- Firm location
- Veenendaal, N/A, Netherlands
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
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 for recall
A component failure may lead to treatment interruption or incorrect source positioning.
Data sourced from openFDA. This site is unofficial and independent of the FDA.