Nucletron recalls Flexitron brach: Internal cable guide mechanism failure may cause treatment interruptions or incorrect radiation positioning. Affected units have specific UDI codes.
A component failure may lead to treatment interruption or incorrect source positioning.
Nucletron is recalling Flexitron brachytherapy afterloader systems due to a potential internal cable guide failure that could interrupt radiation treatment or cause incorrect source positioning. This is a serious issue for medical users who rely on precise radiation therapy.
The internal check cable guide mechanism can become displaced during operation, causing the check cable to damage. This may lead to treatment interruptions or, in very rare cases, incorrect radiation source positioning and treatment errors.
Medical professionals using Nucletron Flexitron brachytherapy systems for radiation treatment are most at risk. Patients receiving treatment with these systems may also be affected.
Check for the UDI code (01)08717213051126 (11)171127 (21)FT00340 (240)136149 on the device. The recall applies to Nucletron Flexitron brachytherapy afterloader systems sold with this specific UDI.
Look for the UDI code (01)08717213051126 (11)171127 (21)FT00340 (240)136149 on the device to confirm if it's affected.
The recall addresses potential treatment interruptions or incorrect radiation positioning, which could affect patients receiving treatment with the affected systems.
Check for the UDI code (01)08717213051126 (11)171127 (21)FT00340 (240)136149 on the device. This specific UDI identifies the affected units.
The recall does not specify a remedy, so affected users should contact Nucletron directly for guidance.
We’ve drafted a message you can send Nucletron to request your refund or repair — edit it as you like.
Subject: Recall Z-0772-2020 — Nucletron Nucletron Hello, I own a Nucletron that is covered by recall Z-0772-2020 from Nucletron. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
