FDA (Devices) recall action 98330
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
Software anomaly in the patient positioning system may result in positional discrepancy.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
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.
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.