—#150975

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.

FDA product code: IYN — System, Imaging, Pulsed Doppler, Ultrasonic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K123622
Affected lot / code info: 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.

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc.
Address: 685 E Middlefield Rd, Mountain View, California 94043-4045

Distribution

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

Timeline

Recall initiated: 2016-11-07
Posted by FDA: 2016-11-28
Terminated: 2017-05-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #150975. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.