PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachi PROBEAT with DSSS is a medical device designed to prod
FDA device recall Z-1838-2015 · posted 2015-07-18 · Terminated
Recall details
- Recalling firm
- Hitachi America, Ltd., Power Systems Division
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LHN
- Quantity affected
- 3
- Distribution
- Distribution in US (Texas) and Japan
- Date initiated
- 2015-04-21
- Date posted
- 2015-07-18
- Date terminated
- 2016-03-24
- Location
- Houston, TX
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM (K073059) | Hitachi, Ltd., Power Systems Group | 2007-12-10 |