FDAFDA · Alimentos y medicamentos·N.º oficial Z-2234-2014
Vital Sync" VPMP & IM, software, V2.4. (DVD), packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. The Vital Sync Virtual Patient Monitoring Platform is intended to be used by healthcare professionals for the following purposes: 1) To remotely consult regarding a patients status; and 2) To remotely review near real-time patient data, waveforms and alarms in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner.
Publicado el 20 de agosto de 2014 · Inicio del retiro: 17 de julio de 2014
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
Covidien is conducting a field correction of the Vital Sync Virtual Patient Monitoring Platform and Informatics Manager due to a mismatch between the alarm priority on the medical devices and the Vital Sync system.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Nellcor Puritan Bennett Inc. (dba Covidien LP)
- Distribuidor
- US distribution to states of: LA, IL, MS, CO, IN, GA, CA and TX.
- Lote
- Model # 10007101; Lot # 14A0041IN
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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