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U.S. Department of Health and Human Services

Class 2 Device Recall ACUSON AcuNav ultrasound catheters

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 Class 2 Recall
ACUSON AcuNav ultrasound catheters
see related information
Date Posted March 23, 2011
Recall Status1 Terminated on April 01, 2011
Recall Number Z-1745-2011
Recall Event ID 52904
Premarket Notification
510(K) Numbers
K033650  K071234  K992631 
Product Classification Catheter, Intravascular, Diagnostic - Product Code DQO
Product Siemens Medical Solutions USA, Inc., ACUSON AcuNav ultrasound catheters when using SwiftLink catheter connectors; Model Number: 10348560.
Code Information Serial Numbers: Between 80720001 and 82920068
Recalling Firm/
Siemens Medical Solutions USA, Inc.
1230 Shorebird Way
P.O. Box 7393
Mountain View, California 94043
For Additional Information Contact Christine Dunbar
Manufacturer 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.
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DQO and Original Applicant = ACUSON CORP.
510(K)s with Product Code = DQO and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.