There is a complaint regarding internal check cable guide… recallZ-0772-2020 · Nucletron BV · initiated Nov 18, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Nucletron BV or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
A component failure may lead to treatment interruption or incorrect source positioning.
FDA root cause category: Process control
What the company is doing
The recalling firm will send a Field Safety Notice 806-01-BTD-001 to all affected customers. The notice informs user of the specific product and version numbers affected by the issue, and any work arounds that can be used to avoid the issue. A copy of the Field Safety Notice is to be kept with the most current labeling and all personnel working with the product should be made aware of the content of the letter. Customers are instructed to complete and return the Field Safety Notice Acknowledgement form to their local Eleka representative as soon as possible and no longer than 30 days from receipt.
Recall details
- Recall number
- Z-0772-2020
- Status
- Terminated
- Initiated by the company
- Nov 18, 2019
- Recalling firm
- Nucletron BV
- Quantity
- 383
- Product code
- JAQ
- FDA submissions
- K070574
- Distribution
- Distribution in United States and worldwide
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.
Code information (models, lots, serial numbers)
REF 136149A02; UDI: (01)08717213051126 (11)171127 (21)FT00340 (240)136149
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Flexitron HDR 136149Nucletron B.V. · System, applicator, radionuclide, remote-controlled1 recall3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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