Brand Name: PROBEAT Product Name: PROBEAT-FR recall
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…
Why was Brand Name: PROBEAT Product Name: PROBEAT-FR 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Code: UDI:(01)04560333350204(11)240112(21)PTFR-01
- Product
- 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…
- Recalling firm
- Hitachi America, Ltd., Particle Therapy Division
- Quantity
- 1
- Distribution
- U.S. Nationwide distribution in the states of TN, TX, and WA.
- Recall date
- September 18, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)