Z-0772-2020Class II

There is a complaint regarding internal check cable guide mechanism failure for the Nucletron Flexitron...

Name: Z-0772-2020 There is a complaint regarding internal check cable guide mechanism failure for the Nucletron Flexitron...
Creator: Nucletron BV
Published: 2019-11-18
License: https://open.fda.gov/license/

Nucletron BV / initiated 2019-11-18 / Terminated / root cause: manufacturing process

FDA source

Nucletron BV began a recall of There is a complaint regarding internal check cable guide mechanism failure for the Nucletron Flexitron brachytherapy afterloader system. Due to an obstruction... on 2019-11-18. FDA classified it as Class II and gives the reason as "A component failure may lead to treatment interruption or incorrect source positioning". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0772-2020
Classification: Class II
Status: Terminated
Initiated: 2019-11-18
Posted: 2020-01-02
Terminated: 2023-03-28
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.
Product code: JAQ System, Applicator, Radionuclide, Remote-Controlled
Reason for recall: A component failure may lead to treatment interruption or incorrect source positioning.
Root cause tag: manufacturing process
FDA 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 in commerce: 383
Distribution: Distribution in United States and worldwide
Product codes and lots: REF 136149A02; UDI: (01)08717213051126 (11)171127 (21)FT00340 (240)136149

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0772-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0772-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-08	2020-01-02

Product code JAQ

K070574Class IIFlexitronIsodose Control B.V. / cleared 2007-04-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)