Z-1838-2015 Class II Terminated
FDA device recall Z-1838-2015 was initiated by Hitachi America, Ltd., Power Systems Division on April 21, 2015 and is designated Class II. 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 s… The recall status is terminated (terminated March 24, 2016). Affected quantity: 3.
Recall Details
- Product Type
- Devices
- Report Date
- July 29, 2015
- Initiation Date
- April 21, 2015
- Termination Date
- March 24, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3
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.
Distribution Pattern
Distribution in US (Texas) and Japan
Code Information
No serial number or lot code. Each system is designed for a specific facility therefore no codes are needed for traceability