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Brand Name: PROBEAT recallZ-3127-2024 · Hitachi America, Ltd., Particle Therapy Division · initiated May 27, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Hitachi America, Ltd., Particle Therapy Division or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Software design

What the company is doing

Between 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 -

Recall details

Recall number
Z-3127-2024
Status
Open, Classified
Initiated by the company
May 27, 2024
Posted by the FDA
Sep 12, 2024
Recalling firm
Hitachi America, Ltd., Particle Therapy Division
Quantity
1
Product code
LHN
FDA submissions
K232032
Distribution
U.S. Nationwide distribution in the states of TN, TX, and WA.

Product description

Brand 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 (models, lots, serial numbers)

Lot Code: This products has no UDI. Serial No.: 2015B01

Other devices under the same FDA submission

1 device cleared under K232032 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 94928).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page