Siemens Medical Solutions USA, Inc. Siemens Medical Solutions USA, Inc., ACUSON AcuNav ultrasound catheters when using SwiftLink catheter connectors; Model Number: 10348560. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Siemens Medical Solutions USA, Inc., ACUSON AcuNav ultrasound catheters when using SwiftLink catheter connectors; Model Number: 10348560.
Brand
Siemens Medical Solutions USA, Inc.
Lot Codes / Batch Numbers
Serial Numbers: Between 80720001 and 82920068
Products Sold
Serial Numbers: Between 80720001 and 82920068
Siemens Medical Solutions USA, Inc. is recalling Siemens Medical Solutions USA, Inc., ACUSON AcuNav ultrasound catheters when using SwiftLink cathet due to Screen Image Quality. An assembly issue on SwiftLink connectors may cause reduced/degraded image quality when using ACUSON AcuNav ultrasound catheter . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Screen Image Quality. An assembly issue on SwiftLink connectors may cause reduced/degraded image quality when using ACUSON AcuNav ultrasound catheter transducers.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026