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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 Device Recall ACUSON AcuNav ultrasound catheters see related information
Date Initiated by Firm March 20, 2009
Date Posted March 23, 2011
Recall Status1 Terminated 3 on April 01, 2011
Recall Number Z-1745-2011
Recall Event ID 52904
510(K)Number K071234  K033650  K992631  
Product Classification ultrasound catheter - 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 CA 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		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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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