Events

Recall of Device Recall SERVOi

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
    37089
  • Event Risk Class
    Class 2
  • Event Number
    Z-0372-2007
  • Event Initiated Date
    2006-05-23
  • Event Date Posted
    2007-01-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-04-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49893
  • 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
    Reported failures of the servo-i ventilators user interface system causing technical errors and increased fault frequencies. switches may be activated unintentionally, or a function not activate when the switch is selected. direct access knobs may not function or change the parameter in the wrong direction compared to how they are turned.
  • Action
    Maquet sent an ''Extended Warranty'' letter on May 23, 2006. On March 13, 2007, Maquet issued a Recall Notification letter to all customers stating that they will replace all PC1777 boards in the serial number range 2400-3300, which have not previously been replaced. A safety alert letter was included outlining the failure indication and effect for the user of the failures, as well as, how to identify whether the Servo-i unit has shown any failure indications.

Device

Device Recall SERVOi
  • Model / Serial
    Article # 64-87-800 Serial numbers 02400 - 03300
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide
  • Product Description
    Ventilator System SERVO-i V3.1 PC1777 || Maquet Critical Care
  • Manufacturer
    MAQUET Inc.

Manufacturer

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