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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- 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
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