Recalls / —
—#84253
Product
Siemens Medical Solutions USA, Inc., ACUSON AcuNav ultrasound catheters when using SwiftLink catheter connectors; Model Number: 10348560.
- FDA product code
- DQO — Catheter, Intravascular, Diagnostic
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K033650, K071234, K992631
- Affected lot / code info
- Serial Numbers: Between 80720001 and 82920068
Why it was recalled
Screen Image Quality. An assembly issue on SwiftLink connectors may cause reduced/degraded image quality when using ACUSON AcuNav ultrasound catheter transducers.
Root cause (FDA determination)
Process design
Action the firm took
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.
Recalling firm
- Firm
- Siemens Medical Solutions USA, Inc.
- Address
- 1230 Shorebird Way P.O. Box 7393, Mountain View, California 94043
Distribution
- Distribution pattern
- Distribution in US and Internationally.
Timeline
- Recall initiated
- 2009-03-20
- Posted by FDA
- 2011-03-23
- Terminated
- 2011-04-01
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #84253. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.