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.
FDA Recall Z-1838-2015 · Posted 2015-07-18
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Recalling FirmHitachi America, Ltd., Power Systems Division
Recall StatusTerminated
Product CodeLHN
Date Initiated2015-04-21
Date Terminated2016-03-24
Product Quantity3
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.
Firm Action
The recalling firm notified the one consignee about the incident that occurred in Japan on 4/7/15, then gave them an update on 4/13/15 and 4/21/15. The written notification had details for the consignee on how to prevent the device from malfunctioning. The recalling firm also had held conversations with the consignee to discuss the issue and revised work instructions via telephone conference and on site Hitachi personnel.
Root Cause
Device Design
Distribution Pattern
Distribution in US (Texas) and Japan
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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