KinetDx 4.0 Ultrasound Image Management System.
FDA device recall Z-1235-06 · posted 2006-07-13 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions, USA, Inc
- Reason for recall
- The cardiologist's report comments may not be retained by the system due to a software bug.
- Action taken
- In April 2006, Siemens' field force was issued instructions to visit each customer location and to complete the software upgrades within six months.
- Root cause
- Other
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 244
- Distribution
- Nationwide.
- Date initiated
- 2006-04-06
- Date posted
- 2006-07-13
- Date terminated
- 2007-05-01
- Location
- Ann Arbor, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| KINETDX (K041029) | Siemens Medi Cal Solutions, Inc. | 2004-07-08 |