Siemens Medical Solutions USA, Inc., ACUSON AcuNav ultrasound catheters when using SwiftLink catheter connectors; Model
FDA device recall Z-1745-2011 · posted 2011-03-23 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- Screen Image Quality. An assembly issue on SwiftLink connectors may cause reduced/degraded image quality when using ACUSON AcuNav ultrasound catheter transducers.
- Action taken
- Siemens Field correction was initiated on 3/20/2009. A device correction letter was distributed to all affected users, with a description of the problem and its corrective actions. Siemens service personnel will make a site visit.
- Root cause
- Process design
- Status
- Terminated
- Product code
- DQO
- Quantity affected
- 21 units
- Distribution
- Distribution in US and Internationally.
- Date initiated
- 2009-03-20
- Date posted
- 2011-03-23
- Date terminated
- 2011-04-01
- Location
- Mountain View, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F (K071234) | Siemens Medical Solutions USA, Inc. | 2007-06-29 |
| ACUNAV 90/10 DIAGNOSTIC ULTRASOUND CATHETER (K033650) | Siemens Medical Solutions USA, Inc. | 2004-02-24 |
| ACUNAV DIAGNOSTIC ULTRASOUND CATHETER (K992631) | Acuson Corp. | 1999-12-15 |