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U.S. Department of Health and Human Services

Class 2 Device Recall 4Z1c Transducer

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  Class 2 Device Recall 4Z1c Transducer see related information
Date Initiated by Firm July 10, 2009
Date Posted May 05, 2011
Recall Status1 Terminated 3 on May 05, 2011
Recall Number Z-2149-2011
Recall Event ID 53211
510(K)Number K072365  
Product 4Z1c Matrix Array Transducer, model number 10033682, used with ACUSON SC2000 ultrasound systems, model number 10433816, manufactured by Siemens Medical Solutions, Ultrasound Business Unit, Mountain View, CA.

The 4Z1c transducer is a special purpose ultrasound transducer designed to help clinicians perform adult echocardiography and pre-operative and intra-operative surgical assessments. Secondary applications include pediatric echocardiography, primarily benefiting older and larger pediatric populations, general abdominal and intra-operative pediatric abdominal imaging and peripheral vessel imaging.
Code Information seial numbers
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc.
1230 Shorebird Way
P.O. Box 7393
Mountain View CA 94043
For Additional Information Contact Kristen Dorrough
650-694-5993
Manufacturer Reason
for Recall		 Burn risk-- due to coolant leaks, patients may suffer burns or blisters due to increased temperature.
FDA Determined
Cause 2		 Equipment maintenance
Action A customer safety advisory notification was sent out to customers on 7/10/09, and a mandatory software update will also be conducted.
Quantity in Commerce 42 units
Distribution Nationwide. Foreign: Japan, Italy, South Korea, Singapore, Yemen, Germany, Australia, and Greece.
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 = and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI
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