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U.S. Department of Health and Human Services

Class 2 Device Recall 4Z1c matrix array transducer

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  Class 2 Device Recall 4Z1c matrix array transducer see related information
Date Initiated by Firm September 29, 2010
Date Posting Updated December 28, 2010
Recall Status1 Terminated 3 on October 04, 2011
Recall Number Z-0826-2011
Recall Event ID 57289
510(K)Number K072365  
Product Classification System, imaging, pulsed doppler, ultlrasonic - Product Code IYN
Product 4Z1c matrix array transducer which is used with ACUSON SC2000 ultrasound system.
Siemens Medical Solutions USA, Inc.
Business Unit Ultrasound
1230 Shorebird Way
Mountain View, CA 94043

Intended use: 4Z1 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 Pinta-operative pediatric abdominal imaging and peripheral vessel imaging.
Code Information Material number: 10433816:, Serial numbers: , 82638701, 82741703, 84254503, 84355608, 84455108, 84754522, 84857919, 91861815, 84858401, 84655617, 91654526, 83044913, 90261810, 90864208, 01288401, 61101009, 61601024, 81631208, 83146817, 83251905, 83751103, 83752419, 84455113, 84557302, 84753934, 84857907, 85056212, 91503602, 93771403, 94982205, 83650009, 90656713, 95183003, 84456707, 84153940, 84857908, 84857918, 84953903, 92068501, 92256206, 82540305, 84053927, 83853304, 84656203, 94065109

Recalling Firm/
Siemens Medical Solutions USA, Inc.
1230 Shorebird Way
P.O. Box 7393
Mountain View CA 94043
For Additional Information Contact Sheila Pickering
Manufacturer Reason
for Recall
There is the possibility of a short occurring in the transducer which could cause focal heating on the probe face.
FDA Determined
Cause 2
Action SIEMENS issued a filed correction in the form of a "Customer Safety Advisory Notification" initiated on September 29, 2010 and mailed to customers by Federal Express on the same day. The notification described the product, problem and actions to be taken by the customers. The customers were instructed to examine the 4Z1c transducer prior to use (Note: if transducer does not show a blister on its front face or does not feel unusually when it is safe for use); to immediately discontinue use and contact their local Siemens representative to get issue resolved, if the transducers developed a hot spot that exhibits a visible blister on the patient contact surface and feels hot to the touch during operation, and to pass this notice on to all those within their organization who need to be aware. If you have any questions, please contact (650) 969-9112 or (800) 422-8766.
Quantity in Commerce 196 units both Transducer and ACUSon SC2000
Distribution Worldwide Distribution: USA and countries including: Australia, Belgium, Brazil, China, Czech Republic, Finland, France, Germany, India, Ireland, Italy, Japan, Kenya, Malaysia, Netherlands, Norway, Portugal, South Korea, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom.
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 = IYN and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI