Company: Hitachi America, Ltd., Power Systems Division
Date of Enforcement Report: 7/29/2015
Class lI:
PRODUCT
PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachis 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 Number Z-1838-2015
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. As a result of the investigation, the company determined that the irradiation control system may be potentially affected when rebooting a part of the control system.
RECALLING FIRM/MANUFACTURER
Hitachi America, Ltd., Power Systems Division, Houston, TX on 4/21/2015 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
3
DISTRIBUTION
US NationwideTexas and Japan
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