FDAFDA · Alimentos y medicamentos·N.º oficial Z-0667-2017
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.
Publicado el 7 de diciembre de 2016 · Inicio del retiro: 7 de noviembre de 2016
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Firm received reports about "acquisition errors" and the deterioration of material covering the articulating section of the Z6Ms transesophageal transducer.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Siemens Medical Solutions USA, Inc.
- Distribuidor
- Worldwide Distribution - US (nationwide) Internationally to AUSTRIA, GERMANY, SOUTH AFRICA, NETHERLANDS, MAURITIUS, MEXICO, and ITALY, JAPAN, SWEDEN
- Lote
- 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.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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