Recall Z-1892-2019— Hitachi America, Ltd., Power Systems Division

Name: FDA recall Z-1892-2019
Creator: U.S. Food and Drug Administration
Published: 2019-04-15

Class II · Terminated

Class II FDA medical device recall by Hitachi America, Ltd., Power Systems Division, initiated 2019-04-15, terminated 2020-04-24. It names 2 FDA 510(k) clearances: K152592, K151132. Product: PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.. Reason: 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..

Recalling firm: Hitachi America, Ltd., Power Systems Division
Classification: Class II
Status: Terminated
Initiated: 2019-04-15
Terminated: 2020-04-24
Firm location: Houston, TX, United States

510(k) clearances named in this recall

2 on FDA's record

K152592 — PROBEAT-VHitachi, Ltd., Health Care Company·cleared 2015-11-02
K151132 — PROBEAT-VHitachi, Ltd., Health Care Company·cleared 2015-06-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.