Hitachi America, Ltd., Power Systems Division: Medical Device Recall in 2019 - (Recall #: Z-1892-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 15, 2019

Date Posted: July 3, 2019

Recall Number: Z-1892-2019

Event ID: 83056

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.

Status: Terminated

Product Quantity: 3

Code Information:

2015B01, A01, A02

Distribution Pattern:

Distributed to accounts located in AZ, MN, and TN. Foreign distribution to Japan.

Voluntary or Mandated:

Voluntary: Firm initiated