Events

Recall of Device Recall SV 300/300A

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
    53843
  • Event Risk Class
    Class 2
  • Event Number
    Z-0588-2010
  • Event Initiated Date
    2009-11-17
  • Event Date Posted
    2010-01-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86656
  • 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
    Some servo ventilators 300/300a and servo ventilator 900c/d/e should not be used with a system that may generate negative pressure below -100 cm h2o (closed system suctioning) due to the risk of damaging the ventilator's pressure transducers.
  • Action
    Maquet sent Device Correction letters commencing 11/17/09 and ending 11/23/09 by Federal Express.

Device

Device Recall SV 300/300A
  • Model / Serial
    Serial numbers 00410-24999. Ventilators in the specific range that are marked with one of the following labels are already equipped with the new type ot pressure transducer. 1. Upgrade EM008/02/1; 2. Upgrade SV300 66 82 745  SV900 66 82 747
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution
  • Product Description
    Maquet Servo Ventilator 300/300A (SV300) || Siemens - Elema AB,
  • Manufacturer
    MAQUET Inc.

Manufacturer

MAQUET Inc.
  • Manufacturer Address
    MAQUET Inc., 45 Barbour Pond Drive, Wayne NJ 07470
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA