FDA Device recall Z-0772-2020
There is a complaint regarding internal check cable guide mechanism failure for the Nucletron Flexitron brachytherapy afterloader system
- FDA Device
- Class II
- terminated
- Published 2020-01-08
On 2020-01-08 the FDA classified a Class II recall of There is a complaint regarding internal check cable guide mechanism failure for the Nucletron Flexitron brachytherapy afterloader system by Nucletron Bv, citing A component failure may lead to treatment interruption or incorrect source positioning.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0772-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-11-18 |
| Published | 2020-01-08 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Nucletron Bv |
| Distribution | n/a |
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.
Identifiers
| code_info | REF 136149A02; UDI: (01)08717213051126 (11)171127 (21)FT00340 (240)136149 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0772-2020%22
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