Recall Z-0667-2017 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Siemens Medical Solutions USA, Inc.
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,
| Date | Nov 28, 2016 (initiated Nov 7, 2016) |
| Status | Terminated |
| Reason | Firm received reports about "acquisition errors" and the deterioration of material covering the articulating section of the Z6Ms transesophageal transducer. |
| Root 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 G |
| Quantity | 33 |
| Distribution | Worldwide Distribution - US (nationwide) Internationally to AUSTRIA, GERMANY, SOUTH AFRICA, NETHERLANDS, MAURITIUS, MEXICO, and ITALY, JAPAN, SWEDEN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123622 | ACUSON Siemens Medical Solutions USA, Inc., Dec 5, 2012 |