| ||Class 2 Recall|
4Z1c matrix array transducer
||December 28, 2010
||Terminated on October 04, 2011
|Recall Event ID
System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
||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.
||Material number: 10433816:
|Siemens Medical Solutions USA, Inc.
1230 Shorebird Way
P.O. Box 7393
Mountain View, California 94043
|For Additional Information Contact
|There is the possibility of a short occurring in the transducer which could cause focal heating on the probe face.
||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
||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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K)s with Product Code = IYN and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI