Reported Jul 29, 2015 · Terminated
PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachi PROBEAT with DSSS is a medical device designed to…
Hitachi America, Ltd., Power Systems Division
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hitachi America, Ltd., Power Systems Division · 1840 Old Spanish Trl · Houston, TX · 77054-2002
Is this the product you have?
- PROBEAT WITH DISCRETE
- SPOT SCANNING SYSTEM Product UsageHitachi PROBEAT with DSSS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
- Lot codes and dates
- No serial number or lot code. Each system is designed for a specific facility therefore no codes are needed for traceability
- Amount recalled
- 3
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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