Z-1745-2011

Siemens Medical Solutions USA, Inc., ACUSON AcuNav ultrasound catheters when using SwiftLink catheter...

Name: Z-1745-2011 Siemens Medical Solutions USA, Inc., ACUSON AcuNav ultrasound catheters when using SwiftLink catheter...
Creator: Siemens Medical Solutions USA, Inc.
Published: 2009-03-20
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2009-03-20 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc. began a recall of Siemens Medical Solutions USA, Inc., ACUSON AcuNav ultrasound catheters when using SwiftLink catheter connectors; Model Number: 10348560 on 2009-03-20. The reason FDA records is "Screen Image Quality. An assembly issue on SwiftLink connectors may cause reduced/degraded image quality when using ACUSON AcuNav ultrasound catheter transducers". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1745-2011
Status: Terminated
Initiated: 2009-03-20
Posted: 2011-03-23
Terminated: 2011-04-01
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens Medical Solutions USA, Inc., ACUSON AcuNav ultrasound catheters when using SwiftLink catheter connectors; Model Number: 10348560.
Product code: DQO Catheter, Intravascular, Diagnostic
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 21 units
Distribution: Distribution in US and Internationally.
Product codes and lots: Serial Numbers: Between 80720001 and 82920068

Product code DQO

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)