Recall Z-1838-2015 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Hitachi America, Ltd., Power Systems Division
PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachi PROBEAT with DSSS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
| Date | Jul 18, 2015 (initiated Apr 21, 2015) |
| Status | Terminated |
| Reason | At a PROBEAT III site installed in Japan, the operator of the system found that the radiation was delivered inconsistent with the treatment plan and stopped the irradiation. The irradiation control system may be potentially affected when rebooting a part of the control system. |
| Root cause | Device Design |
| Action | The recalling firm notified the one consignee about the incident that occurred in Japan on 4/7/15, then gave them an update on 4/13/15 and 4/21/15. The written notification had details for the consignee on how to prevent the device from malfunctioning. The recalling firm also had held conversations with the consignee to discuss the issue and revised work instructions via telephone conference and on site Hitachi personnel. |
| Quantity | 3 |
| Distribution | Distribution in US (Texas) and Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073059 | PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Hitachi, Ltd., Power Systems Group, Dec 10, 2007 |