Hitachi Proton Beam Therapy System Recalled Due to Software Anomaly
Hitachi is recalling its Proton Beam Therapy system due to a software anomaly in the patient positioning system that may cause positional discrepancies during treatment.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with a software anomaly in a radiation therapy device that could affect treatment accuracy. The hazard is theoretical with no reported injuries, meeting the rubric criteria for High severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Hitachi, Ltd. Radiation Oncology Systems is recalling 1 unit of its Hitachi Proton Beam Therapy system, model PROBEAT-CR (Serial Number: CRUS01). The recall affects systems distributed in Texas and Washington DC.
The recall is being initiated due to a software anomaly in the patient positioning system that may result in positional discrepancy. This could potentially affect the accuracy of radiation delivery during proton beam therapy treatments.
Healthcare facilities using the affected system should immediately contact Hitachi to arrange for software correction or device evaluation. Patients scheduled for treatment with this device should consult their healthcare provider for guidance.
The FDA classification for this recall is Class II. No illnesses or injuries have been reported in connection with this issue.
The recalled product
- Product
- Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR
- Manufacturer
- Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
- Hazard
- software-anomaly
- patient-positioning-error
- medical-device-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial Number: CRUS01/ UDI: (01)04560333350006(21)CRUS01(11)190920
Distribution
Distributed in 2 states:
- DC
- TX
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