Device Recall Centricity Perinatal and Centricity Intensive Care

  • Modèle / numéro de série
    Centricity Perinatal and Centricity Intensive Care Versions: 6.60, 6.60.9, 6.70.0, 6.70.1, 6.70.5, 6.70.6, 6.80.0, 6.80.1, 6.90.0, 6.90.1, 6.91.1
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of: Australia, Canada, Denmark, Germany, Hong Kong, Korea, South Korea, Thailand and United Kingdom.
  • Description du dispositif
    Centricity Perinatal and Centricity Intensive Care is intended to be used in clinical departments healthcare delivery systems such as a Labor and Delivery, Postpartum Maternal Care, newborn Nursery, critical care units including Neonatal Intensive Care Units (NICU), and may also be used in physicians offices and outpatient clinics. This product is primarily intended to serve the purpose of electronic documentation of clinical data and is designed to accept, transfer, display, calculate, store and manage clinical data. System capabilities provide the user with the ability to acquire data from the medical devices and to document, annotate, display, store, print, export and retrieve patient clinical practice information. This product is intended for professional use only.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    GE Healthcare It, 540 W Northwest Hwy, Barrington IL 60010-3051
  • Société-mère du fabricant (2017)
  • Source
    USFDA