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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/
Manufacturer
Siemens Medical Solutions USA, Inc.
1230 Shorebird Way
P.O. Box 7393
Mountain View, California 94043
For Additional Information Contact Christine Dunbar
650-694-5993
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
PRODUCTION CONTROLS: Process Control
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.
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