Events

Recall of SERVO-U

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
    28275
  • Event Risk Class
    II
  • Event Initiated Date
    2014-04-17
  • 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
    We have had one occurrence of a disconnection from the ventilator tubing which was not detected by the ventilator i.E. no alarms were triggered. this absence of alarms may occur with system version 1.00.05 in invasive ventilation modes in adult and pediatric patient categories and with the low peep alarm turned off by setting it to zero. this absence of alarms does not occur in the neonatal patient category or in non-invasive modes. this absence of alarms does not occur in system version 1.00.06 which is readily available.

Device

SERVO-U
  • Model / Serial
    Model Catalog: 6694800 (Lot serial: 20087); Model Catalog: 6694800 (Lot serial: 20085); Model Catalog: 6694800 (Lot serial: 20065); Model Catalog: 6694800 (Lot serial: 20061); Model Catalog: 6694800 (Lot serial: 20127); Model Catalog: 6694800 (Lot serial: 20088); Model Catalog: 6688600 (Lot serial: 1015); Model Catalog: 6688600 (Lot serial: 1007)
  • Product Description
    SERVO-U
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

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