PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product recall
PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachi PROBEAT with DSSS is a medical device designed to produce and deliver a proton beam…
Why was PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product recalled?
At a PROBEAT III site installed in Japan, the operator of the system found that the radiation was delivered inconsistent with the treatment plan and stopped the irradiation. The irradiation control system may be potentially affected when rebooting a part of the control system.
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?
No serial number or lot code. Each system is designed for a specific facility therefore no codes are needed for traceability
- Product
- PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachi PROBEAT with DSSS is a medical device designed to produce and deliver a proton beam…
- Recalling firm
- Hitachi America, Ltd., Power Systems Division
- Quantity
- 3
- Distribution
- Distribution in US (Texas) and Japan
- Recall date
- July 29, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)