The Recall Desk
HighFDA (Devices)·Z-1892-2019·Announced 2019-07-03

Hitachi PROBEAT-V Proton Therapy System Software Recall

Hitachi is recalling three PROBEAT-V proton therapy systems due to a potential software error that could result in incorrect target positioning during treatment.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk medical device where a software error could lead to incorrect radiation delivery, representing a risk of harm even though no specific injuries are reported in the source text.

Plain-English summary

Hitachi America, Ltd., Power Systems Division is recalling three PROBEAT-V proton therapy systems, specifically software versions 4.8.1S and 5.1M. The recall is due to a potential discrepancy in target position when using the 3D3D matching mode in the Positioning Image Analysis System (PIAS) software.

The affected systems were distributed to accounts located in Arizona, Minnesota, and Tennessee, as well as to Japan. The specific units are identified by codes 2015B01, A01, and A02.

Healthcare facilities using these systems should contact Hitachi for instructions on how to address the software issue to ensure accurate target positioning during radiation therapy.

The recalled product

Product
PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.
Manufacturer
Hitachi America, Ltd., Power Systems Division
Category
Medical Device — Radiation Therapy System
Hazard
Affected units
3

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • 2015B01
  • A01
  • A02

Distribution

Distributed in 3 states:

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