Events

Recall of Device Recall ALGO Newborn Hearing screener

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Natus Medical Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    32518
  • Event Risk Class
    Class 2
  • Event Number
    Z-0985-05
  • Event Initiated Date
    2005-06-27
  • Event Date Posted
    2005-07-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-01-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40255
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Tester, Auditory Impedance - Product Code ETY
  • Reason
    Internal investigation revealed that preamp cable assemblies in the device had not been properly tested, which could lead to potential shock to users.
  • Action
    The firm plans to provide corrections via removal/replacement of the affected units directly to end users in the U.S. and work with distributors to perform removal and correction abroad.

Device

Device Recall ALGO Newborn Hearing screener
  • Model / 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.
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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
    Natus Medical Inc

Manufacturer

Natus Medical Inc
  • Manufacturer Address
    Natus Medical Inc, 1501 Industrial Rd, San Carlos CA 94070
  • Source
    USFDA