Hitachi HI VISION 6500, Model #EUB-6500, Ultrasound Diagnostic Scanner Device, Software Version V04-04 DICOM ServicePack
FDA device recall Z-1005-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Hitachi Medical Systems America Inc
- Reason for recall
- 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.
- Action taken
- The firm notified their Field Service Personnel and end-users by letter on 5/7/04 and 5/25/04.
- Root cause
- Other
- Status
- Terminated
- Product code
- ITX
- Quantity affected
- 3 units
- Distribution
- The devices were shipped to consignees in OH, PA, WI.
- Date initiated
- 2004-05-07
- Date posted
- 2004-07-20
- Date terminated
- 2008-11-01
- Location
- Twinsburg, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO: EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER (K013723) | Hitachi Medical Corp. | 2002-02-06 |