The FDA has classified a Class II recall for Hitachi, Ltd.'s PROBEAT-FR Proton Beam Therapy System, identified as Z-1429-2026. The recall is due to a software anomaly within the patient positioning system, which may lead to positional discrepancies during treatment. This recall impacts systems distributed in Texas and Washington D.C.

Healthcare providers utilizing the Hitachi Proton Beam Therapy System should immediately review their operational procedures for potential impacts of positional discrepancies. While the document does not specify immediate actions for providers, it highlights a critical safety concern that may require recalibration or software updates. Compliance officers should verify the affected systems within their facilities and consult Hitachi for specific remediation guidance to ensure patient safety and regulatory adherence.