Events

Recall of Device Recall SERVO VENTILATOR 300

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
    51473
  • Event Risk Class
    Class 2
  • Event Number
    Z-1252-2009
  • Event Initiated Date
    2009-03-23
  • Event Date Posted
    2009-05-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-11-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80384
  • 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
    Continuous ventilator, facility use - Product Code CBK
  • Reason
    The expiratory valve in the sv 300 ventilator may stay in the open position if the printed circuit board fails.
  • Action
    An "Urgent: Device Correction" letter dated March 23, 2009 was sent by Federal Express to customers. The letter described the affected product, problem, indications, potential hazard and actions for users. Customers were instructed to complete the "Device Correction -- Customer Fax Response" form and return via fax (732-667-1903) to Maquet Inc. RA/QA. Direct questions to your local Maquet Inc. representative.

Device

Device Recall SERVO VENTILATOR 300
  • Model / Serial
    All units manufactured prior to June 2002.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Servo Ventilator 300 (Model SV300) and || Servo Ventilator 300 (Model SV300A). || The SV300 is intended for general and critical ventilatory care for use on adults, pediatric, infant and neonatal patients. The unit is designed to be used at the bedside for intra-hospital transport.
  • Manufacturer
    MAQUET Inc.

Manufacturer

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