Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha: Medical Device Recall in 2026 - (Recall #: Z-1429-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

Product Description:

Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR

Product Classification:

Class II

Date Initiated: February 6, 2026

Date Posted: March 4, 2026

Recall Number: Z-1429-2026

Event ID: 98330

Reason for Recall:

Software anomaly in the patient positioning system may result in positional discrepancy.

Status: Ongoing

Product Quantity: 1

Code Information:

Serial number: PTFR-01/ UDI:(01)04560333350204(11)240112(21)PTFR-01

Distribution Pattern:

US distribution to states of: TX, Washington DC

Voluntary or Mandated:

Voluntary: Firm initiated