Cl II Hitachi PROBEAT

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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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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