Probeat-v recall: Software Issue
PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.
Why was Probeat-v recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
2015B01, A01, A02
- Product
- PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.
- Recalling firm
- Hitachi America, Ltd., Power Systems Division
- Quantity
- 3
- Distribution
- Distributed to accounts located in AZ, MN, and TN. Foreign distribution to Japan.
- Recall date
- July 3, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)