Events

Recall of SERVO-S INTENSIVE CARE VENTILATOR

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
    21837
  • Event Risk Class
    II
  • Event Initiated Date
    2011-05-12
  • 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
    There have been 4 reported instances (not in canada) where servo 1 ventilators have malfuncioned when being used during high dose radio therapy by linear accelerator (linac). they stopped working generated different error codes reset and started again. no permanent damage or harm to the patient occured. we are informing our customers that sorvo-1 and sorvo -s ventilators are not to be used during hight dose radiotherapy by linear accelerator (linac). the manufacturer has never claimed that these devices could be used in this type of environment.

Device

SERVO-S INTENSIVE CARE VENTILATOR
  • Model / Serial
    Model Catalog: 6640440 (Lot serial: > 10 numbers contact mfg); Model Catalog: 6487800 (Lot serial: > 100 numbers contact mfg)
  • Product Description
    SERVO-s VENTILATOR SYSTEM
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

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