Class 2 Device Recall 4Z1c matrix array transducer

• Date Initiated by Firm: September 29, 2010
• Date Posted: December 28, 2010
• Recall Status: Terminated 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/ Manufacturer: Siemens Medical Solutions USA, Inc.; 1230 Shorebird Way; P.O. Box 7393; Mountain View CA 94043
• For Additional Information Contact: Sheila Pickering; 650-694-5398
• 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: Other
• 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