FDA-Device2016-12-07Class II
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 a
Siemens Medical Solutions USA, Inc.
Hazard
Firm received reports about "acquisition errors" and the deterioration of material covering the articulating section of the Z6Ms transesophageal transducer.
Sold states
Worldwide Distribution - US (nationwide) Internationally to AUSTRIA, GERMANY, SOUTH AFRICA, NETHERLANDS, MAURITIUS, MEXICO, and ITALY, JAPAN, SWEDEN
Affected count
33
Manufactured in
685 E Middlefield Rd, Mountain View, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0667-2017Don't want to check this manually?
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