Z-1892-2019 Class II Terminated
FDA device recall Z-1892-2019 was initiated by Hitachi America, Ltd., Power Systems Division on April 15, 2019 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated April 24, 2020). Affected quantity: 3.
Recall Details
- Product Type
- Devices
- Report Date
- July 3, 2019
- Initiation Date
- April 15, 2019
- Termination Date
- April 24, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3
Product Description
PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.
Reason for Recall
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 Pattern
Distributed to accounts located in AZ, MN, and TN. Foreign distribution to Japan.
Code Information
2015B01, A01, A02