Device Recall ALGO Newborn Hearing screener

  • Modelo / Serial
    Product order numbers 010038, 010049, 010050, 010065, 010067, 010073, 010085, 030534, 040664, 040700, 040703, 040847, DM010038, DM010039, DM010049, DM010067, DM010074, LN030534. Serial numbers include P3 0547-P3 3404.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Product was distributed worldwide, to distributors in Canada, Australia/New Zealand, Japan, the European Union, Bahamas, Bermuda, Chile, China, Hong Kong, INdia, Indonesia, Israel, Italy, Kuwait, Luxembourg, Malaysia, Nigeria, Quatar, Romania, Saudi Aabia, Singapore, Slovakia, South Africa, South Korea, Sweden, Switzerland, Taiwan and Thailand.
  • Descripción del producto
    Natus Algo Pre-Amplifier 3 cable assembly (Component of the Algo 3 Newborn Hearing Screener and Algo 3i Newborn Hearing screener, Algo Portable Newborn Hearing Screener, and Algo 2ec Newborn Hearing Screener.)
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Natus Medical Inc, 1501 Industrial Rd, San Carlos CA 94070
  • Source
    USFDA