Events

Recall of SERVO 900 D 110V/60HZ SERVO VENTILATOR 900D

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MAQUET-DYNAMED 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
    79002
  • Event Risk Class
    III
  • Event Initiated Date
    2009-11-18
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    A letter to inform users not to use a system that may generate negative pressure below -100 cm h2o due to the risk of damaging the ventilator's pressure transducers if applied improperly.

Device

SERVO 900 D 110V/60HZ SERVO VENTILATOR 900D
  • Model / Serial
    Model Catalog: 9098492 (Lot serial: S/N 01001-188499); Model Catalog: 6150614 (Lot serial: S/N 00410-24999); Model Catalog: 6424712 (Lot serial: S/N 00410-24999); Model Catalog: 6437631 (Lot serial: S/N 00410-24999); Model Catalog: 6437805 (Lot serial: S/N 00410-24999); Model Catalog: 6932552 (Lot serial: S/N 01001-188499)
  • Product Description
    SERVO 900D
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

MAQUET-DYNAMED INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    HC