BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-0667-2017 · Initiated November 7, 2016

    Recall

    Recall Number
    Z-0667-2017
    Event Number
    75639
    Firm
    Siemens Medical Solutions USA, Inc.
    FEI Number
    2936884
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 7, 2016
    Posted
    November 28, 2016
    Terminated
    May 26, 2017
    Address
    685 E Middlefield Rd, Mountain View, CA, 94043-4045

    Description

    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.

    Reason

    Firm received reports about "acquisition errors" and the deterioration of material covering the articulating section of the Z6Ms transesophageal transducer.

    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.

    Distribution

    Worldwide Distribution - US (nationwide) Internationally to AUSTRIA, GERMANY, SOUTH AFRICA, NETHERLANDS, MAURITIUS, MEXICO, and ITALY, JAPAN, SWEDEN

    Quantity

    33