Z-3126-2024Class II

Brand Name: PROBEAT Product Name: PROBEAT-CR Model/Catalog Number: N/A Software Version: N/A Product...

Name: Z-3126-2024 Brand Name: PROBEAT Product Name: PROBEAT-CR Model/Catalog Number: N/A Software Version: N/A Product...
Creator: Hitachi America, Ltd., Particle Therapy Division
Published: 2024-05-27
License: https://open.fda.gov/license/

Hitachi High-Tech America, Inc. Radiation Therapy Division / initiated 2024-05-27 / Open, Classified / root cause: software

FDA source

Hitachi America, Ltd., Particle Therapy Division began a recall of Brand Name: PROBEAT Product Name: PROBEAT-CR Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-CR is a proton beam irradiation... on 2024-05-27. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-3126-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-27
Posted: 2024-09-12
Recalling firm: Hitachi High-Tech America, Inc. Radiation Therapy Division
Product: Brand Name: PROBEAT Product Name: PROBEAT-CR Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-CR 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
Product code: LHN System, Radiation Therapy, Charged-Particle, Medical
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.
Root cause tag: software
FDA root cause: Software design
Action: 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 -
Quantity in commerce: 1
Distribution: U.S. Nationwide distribution in the states of TN, TX, and WA.
Product codes and lots: Lot Code: (01)04560333350006(21)CRUS01(11)190920

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3126-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3125-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-12
Z-3126-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-12
Z-3127-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-12

Product code LHN

K232032Class IIProbeat-FrHitachi, Ltd. Radiation Oncology Systems, Kashiwanoha / cleared 2024-01-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)