Class 2 Device Recall 18L6HD transducer

• Date Initiated by Firm: March 30, 2017
• Create Date: April 24, 2017
• Recall Status: Terminated on March 21, 2019
• Recall Number: Z-1875-2017
• Recall Event ID: 76987
• 510(K)Number: K163635
• Product Classification: System, imaging, pulsed doppler, ultrasonic - Product Code IYN
• Product: 18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C;; ; Model numbers:; 18L6 HD transducer  10041227 & 10789400; S1000  10441701; S2000  10041461; S2000 (Refurb) - 10440017; S3000  10441730; ; ; Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
• Code Information: US serial numbers: 200113 200245 200394 200695 200706 200715 200935 201159 201256 201916 202076 202551 202559 202584 202587 202600 202626 202937 203212 205736 205850 206286 206919 206949 207048 207073 207087 207096 207099 207551 207552 207560 207566 207572 207648 207713 208114 208142 208153 208984 209481 210012 210017 210061 210128 210143 210157 210163 210173 210188 210241 210274 210324 210334 210439 210508 210569 210584 210664 210665 210666 210679 210703 210735 210737 210742 210744 210747 210753 210811 210832 210861 210873 210979 210981 211018 211026 211070 211093 211124 211138 211158 211167 211244 211249 211302 211316 211325 211335 211336 211337 211338 211340 211347 211352 211354 211355 211357 211362 211375 211460 211480 211499 211513 211549 211581 211626 211627 211637 211639 211643 211647 211648 211649 211650 211653 211659 211666 211715 211717 211720 211723 211732 211733 211745 211750 211751 211752 211767 211769 211770 211778 211782 211788 212069 212070 212082 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• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc.; 685 E Middlefield Rd; Mountain View CA 94043-4045
• For Additional Information Contact: Scott Christiansen; 650-694-5398
• Manufacturer Reason for Recall: When scanning with the 18L6 HD transducer on the ACUSON HELX" Evolution with Touch Control, the ultrasound system may display a triple image or an image with a dark band. For the triple image issue, the system repeats one-third of the aperture, but does not display the full field of view.
• FDA Determined Cause: Software design
• Action: Siemens sent an Customer Safety Advisory Notification via certified mail on March 30, 2017. OUS consignees are notified through the implementation of the field correction with the distributors for all countries. Letters advised users of the issues with software version VD10A or VD10C and provided steps to avoid the potential risk. Once available, all systems will be updated with corrected software. For further questions, please call (650) 694-5398.
• Quantity in Commerce: 2,045 systems
• Distribution: Worldwide Distribution - USA (nationwide) Distribution and to the countries of : United Arab Emirates, Argentina, Armenia, Austria, Australia, Azerbaijan, Bahrain,Bangladesh, Belgium, Bolivia, Brazil, Canada, Chile, Columbia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, El Salvador, Ethiopia, Egypt, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Norway, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, Venezuela, Vietnam and 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 Group