Recall Z-1838-2015— Hitachi America, Ltd., Power Systems Division
Class II · Terminated
Class II FDA medical device recall by Hitachi America, Ltd., Power Systems Division, initiated 2015-04-21, terminated 2016-03-24. It names one FDA 510(k) clearance: K073059. 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 for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.. Reason: 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..
- Recalling firm
- Hitachi America, Ltd., Power Systems Division
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-04-21
- Terminated
- 2016-03-24
- Firm location
- Houston, TX, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachi 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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.