Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR
Summary
The FDA issued a Class II for Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR by Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha. Reason: Software anomaly in the patient positioning system may result in positional discrepancy..
Details
Source
Device Recall
External ID
Z-1430-2026
Action Date
2026-03-04
Status
Ongoing
Category
device
Product Description
Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR
Lot/Code Info: Serial Number: CRUS01/ UDI: (01)04560333350006(21)CRUS01(11)190920
Quantity Affected: 1 unit
Reason for Recall
Software anomaly in the patient positioning system may result in positional discrepancy.
Distribution
US distribution to states of: TX, Washington DC
Type: Voluntary: Firm initiated
Recall Initiated: 2026-02-06
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 178 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha has 4 FDA actions in our database, including 2 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha have FDA actions?
Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha has 4 FDA actions in our database, including 2 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1430-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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