Reported Sep 18, 2024 · Ongoing
Brand Name: PROBEAT Product Name: PROBEAT-CR Model/Catalog Number: N/A Software Version: N/A Product Description: The…
Hitachi America, Ltd., Particle Therapy Division
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hitachi America, Ltd., Particle Therapy Division · 2535 Augustine Dr, 2nd fl · Santa Clara, CA · 95054
Is this the product you have?
- Brand NamePROBEAT
- Product NamePROBEAT-CR
- Model/Catalog NumberN/A
- Software VersionN/A
- Product DescriptionThe PROBEAT-CR is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site
- ComponentN/A
- Lot codes and dates
- Lot Code(01)04560333350006(21)CRUS01(11)190920
- Amount recalled
- 1
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
During positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display CBCT images that are insufficient in number.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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