Houston, TX, United States
Hitachi America, Ltd., Power Systems Division recalls
1 recall recorded since 2018, most recently on 15 April 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
- 15 April 2019
- Terminated
- 24 April 2020
- Reason
- There is a potential for a discrepant target position when using 3D3D matching mode in PIAS (Positioning Image Analysis System) software installed in the PROBEAT-V, proton therapy systems.
- Distribution
- Distributed to accounts located in AZ, MN, and TN. Foreign distribution to Japan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1892-2019
- PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.
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.