Class 2 Device Recall ACUSON SC2000

• Date Initiated by Firm: November 07, 2016
• Date Posted: November 28, 2016
• Recall Status: Terminated on May 26, 2017
• Recall Number: Z-0667-2017
• Recall Event ID: 75639
• 510(K)Number: K123622
• Product Classification: System, imaging, pulsed doppler, ultrasonic - Product Code IYN
• Product: Z6Ms transesophageal transducers used on ACUSON SC2000 ultrasound systems, Z6Ms model 10436113.; ; Radiology:; The ACUSON SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Neurological-skeletal Conventional, and Musculo-skeletal Superficial applications. The system; also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctive with other medical data obtained by a physician for clinical diagnosis purposes.
• Code Information: Model number 10436113 -Z6Ms Transesophageal tranducer. US Serial numbers: 63229007 63229008 63432010 63530518 63322007 63230009 63260584 63530516 63432007 63319012 63332004 63325007 63328003 63328007 63332002 63029015 63329017 63230003. Foreign serial numbers: 63260585 63230002 63029009 63329018 63229011 63432015 63229012 63430524 63029016 63360611 63360612 63432017.
• 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: Firm received reports about "acquisition errors" and the deterioration of material covering the articulating section of the Z6Ms transesophageal transducer.
• FDA Determined Cause: Device Design
• Action: Siemens sent a Customer Safety Advisory Notification letter to all affected customers on November 7, 2016 by certified mail advising them of the issue and identified steps that can be taken to avoid potential risk of this issue. This letter has been released first in English while translations are being completed. Once the translations are complete customers in the countries who require translations will receive the letter. Prior to this mailing, ECO #641310 was released on July 5, 2016 and implemented into forward production on July 28, 2016 (SN 63028009) to correct the susceptibility to Gastro-flex circuit corrosion and electro migration. The ECO changed standard copper traces and traditionally applied solder mask on the circuit to fully gold plated traces with a dry film solder mask. ECO #645821 was released on September 8, 2016 date and implemented into forward production on September 8, 2016 (SN 63530013) to correct susceptibility to articulation sleeve damage. The ECO changed the articulation sleeve material from C-Flex to Viton. For questions regarding this recall call 650-694-5398.
• Quantity in Commerce: 33
• Distribution: Worldwide Distribution - US (nationwide) Internationally to AUSTRIA, GERMANY, SOUTH AFRICA, NETHERLANDS, MAURITIUS, MEXICO, and ITALY, JAPAN, SWEDEN
• 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.