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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 Transducersee related information
Date Initiated by FirmJuly 10, 2009
Date PostedMay 05, 2011
Recall Status1 Terminated 3 on May 05, 2011
Recall NumberZ-2149-2011
Recall Event ID 53211
510(K)NumberK072365 
Product4Z1c 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
FEI Number 2936884
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc.
1230 Shorebird Way
P.O. Box 7393
Mountain View CA 94043
For Additional Information ContactKristen 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
ActionA customer safety advisory notification was sent out to customers on 7/10/09, and a mandatory software update will also be conducted.
Quantity in Commerce42 units
DistributionNationwide. 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) Database510(K)s with Product Code =
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