Events

Recall of Servo-i Ventilator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Maquet 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
    31769
  • Event Risk Class
    Class 2
  • Event Number
    Z-0878-05
  • Event Initiated Date
    2005-03-24
  • Event Date Posted
    2005-06-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-09-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38468
  • 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
    Ventilator, Continuous, Facility Use - Product Code CBK
  • Reason
    Complaints about batteries indicating a satisfying remaining time but after a short time suddenly shut off without giving alarms to indicate short remaining battery back-up time. (power off alarm will be given).
  • Action
    Maquet sent out a Safety alert Letter on 3/31/2005 to all users of the Servo-i.

Device

Servo-i Ventilator
  • Model / Serial
    All Servo-i units with serial numbers below 17617.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The ventilators were distributed nationwide to hosptials and clinics.
  • Product Description
    Servo-i Ventilator
  • Manufacturer
    Maquet Inc

Manufacturer

Maquet Inc
  • Manufacturer Address
    Maquet Inc, 1140 Route 22 East, Bridgewater NJ 08807-2912
  • Source
    USFDA