Veenendaal, N/A, Netherlands
Nucletron BV recalls
1 recall recorded since 2018, most recently on 18 November 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 18 November 2019
- Terminated
- 28 March 2023
- Reason
- A component failure may lead to treatment interruption or incorrect source positioning.
- Distribution
- Distribution in United States and worldwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0772-2020
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.