Events

Recall of BirthNet

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

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
    33769
  • Event Risk Class
    Class 3
  • Event Number
    Z-0115-06
  • Event Initiated Date
    2005-10-13
  • Event Date Posted
    2005-11-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-01-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42415
  • 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
    System, Monitoring, Perinatal - Product Code HGM
  • Reason
    Potential for incorrect weight to be displayed.
  • Action
    On 10/13/04 the firm sent letters to customers advising of the error, and that software to correct the problem will be released the end of October. Service personnel will install new software.

Device

BirthNet

Manufacturer

Spacelabs Medical Incorporated
  • Manufacturer Address
    Spacelabs Medical Incorporated, 5150 220th Ave Se, Issaquah WA 98029-6834
  • Source
    USFDA