Nucletron Flexitron Brachytherapy Afterloader Recalled for Cable Guide Failure
Nucletron BV is recalling 383 Flexitron brachytherapy afterloader systems due to a component failure that may cause treatment interruption or incorrect source positioning.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (radiation treatment errors) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Nucletron BV is recalling 383 units of the Flexitron brachytherapy afterloader system. The recall is due to a complaint regarding a failure of the internal check cable guide mechanism. This issue occurred when an obstruction during the check cable out drive caused the internal guiding tube to become displaced and the check cable to become damaged.
The affected units were distributed in the United States and worldwide. The specific unit identifier is REF 136149A02, with UDI (01)08717213051126 (11)171127 (21)FT00340 (240)136149.
This component failure may lead to treatment interruption or, in a very unlikely scenario, incorrect source positioning and radiation treatment errors. Healthcare facilities should contact Nucletron BV for further instructions on how to address this issue.
The recalled product
- 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…
- Manufacturer
- Nucletron BV
- Affected units
- 383
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- REF 136149A02
- UDI: (01)08717213051126 (11)171127 (21)FT00340 (240)136149
Distribution
Distribution scope not specified by the agency.
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