FDA Enforcement
Class II
Terminated
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.
Recall: Z-1838-2015
·
Reported July 29, 2015
Enforcement
- Recall Number
- Z-1838-2015
- Event ID
- 71056
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Hitachi America, Ltd., Power Systems Division
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 29, 2015
- Initiation Date
- April 21, 2015
- Classification Date
- July 17, 2015
- Termination Date
- March 24, 2016
- Address
- 1840 Old Spanish Trl, N/A, Houston, TX, 77054-2002, United States
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
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.
Code Info
No serial number or lot code. Each system is designed for a specific facility therefore no codes are needed for traceability
Distribution
Distribution in US (Texas) and Japan
Quantity
3