Events

Recall of Device Recall SERVOi Ventilator System

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
    49117
  • Event Risk Class
    Class 2
  • Event Number
    Z-2442-2008
  • Event Initiated Date
    2008-07-08
  • Event Date Posted
    2008-09-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-12-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72798
  • 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 - Product Code CBK
  • Reason
    Maquet became aware of potentially defective crimpings at the point connector attached to the cable in servo-i and servo-s ventilators.
  • Action
    Urgent - Device Correction notices were sent out to all customers on July 7, 2008. The letter informed the customers of the affected product, and associated hazards. The letter instructed customers to take an inventory of the product and it provided actions to be taken until affected products are replaced. Contact Maquet at 1-888-627-8383#1, for assistance.

Device

Device Recall SERVOi Ventilator System
  • Model / Serial
    Article number 64 87 800 Serial numbers: 34034, 34035, 34050, 34052, 34053, 34054, 34058,  34060 through 34083, 34085, 34086, 34087, 34088, 34090, 34096, 34099 through 34287, 34293, 34294, 34295, 34296, 34298, 34299, 34302, 34303, 34305, 34309, 34313, 34315, 34319, 34230, 34323, 34324, 34326, 34329, 34330, 34343, 34345, 34348, 34350, 34357, 34360, 34376, 34384, 34390, 34427, 34490, and 34530.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide.
  • Product Description
    SERVO-i Ventilator System Maquet Critical Care, Solna, Sweden. The product is intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency.
  • Manufacturer
    MAQUET Inc.

Manufacturer

MAQUET Inc.
  • Manufacturer Address
    MAQUET Inc., 1140 US Highway 22, Bridgewater NJ 08807-2958
  • Source
    USFDA