Hitachi America, Ltd., Power Systems Division: Medical Device Recall in 2015 - (Recall #: Z-1838-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: April 21, 2015

Date Posted: July 29, 2015

Recall Number: Z-1838-2015

Event ID: 71056

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.

Status: Terminated

Product Quantity: 3

Code Information:

No serial number or lot code. Each system is designed for a specific facility therefore no codes are needed for traceability

Distribution Pattern:

Distribution in US (Texas) and Japan

Voluntary or Mandated:

Voluntary: Firm initiated