FDA Medical Device Recalls (openFDA)
Nucletron BV: 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.
- Recall number
- Z-0772-2020
- Recalling firm
- Nucletron BV
- 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.
- Status
- Terminated
- Initiated
- 2019-11-18
- Posted
- not on file
- Terminated
- 2023-03-28
- Reason
- A component failure may lead to treatment interruption or incorrect source positioning.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 383
- Distribution
- Distribution in United States and worldwide
- Lot, serial or model codes
- REF 136149A02; UDI: (01)08717213051126 (11)171127 (21)FT00340 (240)136149
- 510(k) numbers
- ["K070574"]
- PMA numbers
- not on file
- Product code
- JAQ
- Firm FEI
- 3002807741
- Firm city
- Veenendaal
- Firm state
- not on file
- Firm country
- Netherlands
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28