Brand Name: PROBEAT Product Name: PROBEAT-FR Model/Catalog Number: N/A Software Version: N/A Product Description: The PR

FDA device recall Z-3125-2024 · posted 2024-09-12 · Open, Classified

Recall details

Recalling firm

Hitachi America, Ltd., Particle Therapy Division

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.

Action taken

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 -

Root cause

Software design

Status

Open, Classified

Product code

LHN

Quantity affected

1

Distribution

U.S. Nationwide distribution in the states of TN, TX, and WA.

Date initiated

2024-05-27

Date posted

2024-09-12

Location

Santa Clara, CA

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