Z-1892-2019Class II

PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system

Name: Z-1892-2019 PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system
Creator: Hitachi America, Ltd., Power Systems Division
Published: 2019-04-15
License: https://open.fda.gov/license/

Hitachi High-Tech America, Inc. Radiation Therapy Division / initiated 2019-04-15 / Terminated / root cause: software

FDA source

Hitachi America, Ltd., Power Systems Division began a recall of PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system on 2019-04-15. FDA classified it as Class II and gives the reason as "There is a potential for a discrepant target position when using 3D3D matching mode in PIAS (Positioning Image Analysis System) software installed in the PROBEAT-V, proton therapy systems". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1892-2019
Classification: Class II
Status: Terminated
Initiated: 2019-04-15
Posted: 2019-06-28
Terminated: 2020-04-24
Recalling firm: Hitachi High-Tech America, Inc. Radiation Therapy Division
Product: PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.
Product code: LHN System, Radiation Therapy, Charged-Particle, Medical
Reason for recall: There is a potential for a discrepant target position when using 3D3D matching mode in PIAS (Positioning Image Analysis System) software installed in the PROBEAT-V, proton therapy systems.
Root cause tag: software
FDA root cause: Software design
Action: The firm informed affected user sites of the recall beginning on April 15, 2019, via an Engineering Document. The firm distributed updated Urgent Medical Device Recall letters in June 2019. The firm stated that the PIAS software would be replaced with the corrected version. Until the software was corrected, users were asked to take the following interim countermeasures: -Limit the number of treatment planning CT slices to odd numbers only. - Create treatment plan only in Head First condition for new patients. - Use the beam limiting device in full open in the lateral direction (same as before). Customers were asked to complete and return the customer response form to the firm. The firm stated that the software correction will be implemented from June 17 - 29, 2019.
Quantity in commerce: 3
Distribution: Distributed to accounts located in AZ, MN, and TN. Foreign distribution to Japan.
Product codes and lots: 2015B01, A01, A02

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1892-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1892-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-03	2019-06-27

Product code LHN

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)