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U.S. Department of Health and Human Services

Class 2 Device Recall PROBEAT

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 Class 2 Device Recall PROBEATsee related information
Date Initiated by FirmMay 27, 2024
Date PostedSeptember 12, 2024
Recall Status1 Open3, Classified
Recall NumberZ-3127-2024
Recall Event ID 94928
510(K)NumberK232032 
Product Classification System, radiation therapy, charged-particle, medical - Product Code LHN
ProductBrand Name: PROBEAT Product Name: PROBEAT-V Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-V 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
Code Information Lot Code: This products has no UDI. Serial No.: 2015B01
Recalling Firm/
Manufacturer		 Hitachi America, Ltd., Particle Therapy Division
2535 Augustine Dr, 2nd fl
Santa Clara CA 95054
For Additional Information ContactYuki Terakado
408-9866300
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionBetween 08/05-09/2024, the firm communicated/hand-delivered an "URGENT: MEDICAL DEVICE RECALL" letter to customers informing them that during positioning in the Positioning Image Analysis Systems (PIAS) 3D3D matching mode, while transferring Cone Beam CT systems (CBCT) images from CT Image Reconstruction Software (CIRS) to PIAS, when the Float Image Selection button on the PIAS screen is pressed, it may display CBCT images that are insufficient in number. This may reveal a clear displacement in the Y-direction (body axis direction) compared to the planning CT. There may potentially be a possibility of completing 3D3D patient positioning approximately 5mm off in the body axis direction (with 5 images missing) and proceeding with treatment. Customers are instructed, until the software has been replaced with the corrected version, all users of the device are directed to follow the interim countermeasure. When users operate as described in the operation manual, no such event should occur. Countermeasure references: Engineering Document: PBT-40E-1042 Instruction for patient positioning assistance using CBCT [PROBEAT-FR] Operation Manual TS.16F0147-1 Page.1-105 / 1-108 [PROBEAT-CR] Operation Manual TS.16F0147-1 Page. 1-4-20 / 1-4-23 [PROBEAT-V] Operation Manual TS.16A1850-1E Page.1-126 / 1-131 For questions/assistance -
Quantity in Commerce1
DistributionU.S. Nationwide distribution in the states of TN, TX, and WA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LHN
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