Brand Name: PROBEAT Product Name: PROBEAT-FR Model/Catalog Number: N/A Software Version: N/A Product Description: Th
Summary
The FDA issued a Class II for Brand Name: PROBEAT Product Name: PROBEAT-FR Model/Catalog Number: N/A Softwa by Hitachi America, Ltd., Particle Therapy Division. Reason: 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.
Details
Source
Device Recall
External ID
Z-3125-2024
Action Date
2024-09-18
Status
Ongoing
Category
device
Product Description
Brand Name: PROBEAT Product Name: PROBEAT-FR Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-FR 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. Component: N/A
Lot/Code Info: Lot Code: UDI:(01)04560333350204(11)240112(21)PTFR-01
Quantity Affected: 1
Reason for Recall
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.
Distribution
U.S. Nationwide distribution in the states of TN, TX, and WA.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-27
Company
Santa Clara, CA
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 257 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Hitachi America, Ltd., Particle Therapy Division has 3 FDA actions in our database, including 3 recalls.
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 America, Ltd., Particle Therapy Division) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Hitachi America, Ltd., Particle Therapy Division have FDA actions?
Hitachi America, Ltd., Particle Therapy Division has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3125-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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