Z-1838-2015Class II

Probeat with Discrete Spot Scanning System

Name: Z-1838-2015 Probeat with Discrete Spot Scanning System
Creator: Hitachi America, Ltd., Power Systems Division
Published: 2015-04-21
License: https://open.fda.gov/license/

Hitachi High-Tech America, Inc. Radiation Therapy Division / initiated 2015-04-21 / Terminated / root cause: design

FDA source

Hitachi America, Ltd., Power Systems Division began a recall of 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... on 2015-04-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1838-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-21
Posted: 2015-07-18
Terminated: 2016-03-24
Recalling firm: Hitachi High-Tech America, Inc. Radiation Therapy Division
Product: 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 code: LHN System, Radiation Therapy, Charged-Particle, Medical
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.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 3
Distribution: Distribution in US (Texas) and Japan
Product codes and lots: No serial number or lot code. Each system is designed for a specific facility therefore no codes are needed for traceability

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1838-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1838-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-17

Product code LHN

K073059Class IIProbeat with Discrete Spot Scanning SystemHitachi, Ltd., Power Systems Group / cleared 2007-12-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)