Z6Ms transesophageal transducers used on ACUSON SC2000 ultrasound systems, Z6Ms model 10436113. Radiology: The ACUSON SC

FDA device recall Z-0667-2017 · posted 2016-11-28 · Terminated

Recall details

Recalling firm

Siemens Medical Solutions USA, Inc.

Reason for recall

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

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

IYN

Quantity affected

33

Distribution

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

Date initiated

2016-11-07

Date posted

2016-11-28

Date terminated

2017-05-26

Location

Mountain View, CA

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