Reported Jan 8, 2020 · Terminated
There is a complaint regarding internal check cable guide mechanism failure for the Nucletron Flexitron brachytherapy…
Nucletron BV
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Nucletron BV · Waardgelder 1 · Veenendaal, N/A · N/A
Is this the product you have?
- 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.
- Lot codes and dates
- REF 136149A02
- UDI(01)08717213051126 (11)171127 (21)FT00340 (240)136149
- Amount recalled
- 383
Why it was recalled
A component failure may lead to treatment interruption or incorrect source positioning.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Nucletron BV recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.