Boonton, NJ, United States
PTW NORTH AMERICA CORPORATION recalls
1 recall recorded since 2018, most recently on 27 August 2021. 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
- 27 August 2021
- Terminated
- 9 February 2024
- Reason
- When a measurement with a PTW detector array is performed with the software BeamAdjust 2.2 or VeriSoft 8.0, a measurement error can occur under specific conditions. This error can lead to a too-low or too-high measured absolute dose which affects patient plan verification results
- Distribution
- US Nationwide distribution in the state of CO.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0479-2022
- Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032
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.