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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
ACUSON AcuNav ultrasound catheters		see related information
Date Posted March 23, 2011
Recall Number Z-1745-2011
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
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.
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.
 
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