Recall Z-1745-2011 ยท DQO Catheter, Intravascular, Diagnostic
Siemens Medical Solutions USA, Inc.
Siemens Medical Solutions USA, Inc., ACUSON AcuNav ultrasound catheters when using SwiftLink catheter connectors; Model Number: 10348560.
| Date | Mar 23, 2011 (initiated Mar 20, 2009) |
| Status | Terminated |
| Reason | Screen Image Quality. An assembly issue on SwiftLink connectors may cause reduced/degraded image quality when using ACUSON AcuNav ultrasound catheter transducers. |
| Root cause | Process design |
| Action | 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. |
| Quantity | 21 units |
| Distribution | Distribution in US and Internationally. |
| FDA record | Open on fda.gov |