Recall Z-1005-04 ยท ITX Transducer, Ultrasonic, Diagnostic
Hitachi Medical Systems America Inc
Hitachi HI VISION 6500, Model #EUB-6500, Ultrasound Diagnostic Scanner Device, Software Version V04-04 DICOM ServicePack 1 and EZU-FC5W.
| Date | Jul 20, 2004 (initiated May 7, 2004) |
| Status | Terminated |
| Reason | Due to a software anomaly, various patient images may be intermixed within a single patient folder, which may result in mis-diagnosis and delay in treatment. |
| Root cause | Other |
| Action | The firm notified their Field Service Personnel and end-users by letter on 5/7/04 and 5/25/04. |
| Quantity | 3 units |
| Distribution | The devices were shipped to consignees in OH, PA, WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013723 | MODIFICATION TO: EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER Hitachi Medical Corp., Feb 6, 2002 |