Hitachi Proton Beam Therapy System Recall Over Positioning Software Issue
Hitachi is recalling one Proton Beam Therapy System due to a software anomaly in the patient positioning system that may cause positional discrepancy during treatment.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which under the rubric corresponds to a severity score of 4 (Severe) because Class II recalls are those where the device could cause temporary or medically reversible adverse health consequences.
Plain-English summary
Hitachi, Ltd. Radiation Oncology Systems is recalling one Hitachi Proton Beam Therapy System (Ref: PROBEAT-FR) because of a software anomaly in the patient positioning system. The anomaly may result in a positional discrepancy, meaning the patient may not be positioned exactly as intended during proton beam therapy.
The recalled unit has serial number PTFR-01 and was distributed in the United States to Texas and Washington, D.C. The UDI for the device is (01)04560333350204(11)240112(21)PTFR-01.
This is an FDA Class II recall, which means the device could cause temporary or medically reversible adverse health consequences, or where the probability of serious health consequences is not remote.
Healthcare facilities using the affected Proton Beam Therapy System should contact Hitachi, Ltd. Radiation Oncology Systems for service and corrective action. No specific consumer action is required beyond awareness of the recall.
The recalled product
- Product
- Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
- Manufacturer
- Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
- Hazard
- software-anomaly
- positioning-error
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: PTFR-01/ UDI:(01)04560333350204(11)240112(21)PTFR-01
Distribution
Distributed in 2 states:
- DC
- TX
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