Events

Recall of POWERLED 700

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
    88856
  • Event Risk Class
    II
  • Event Initiated Date
    2014-03-14
  • 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
    On powerled 700 the ambient light module is a set of three leds that are intended for an easy viewing of and around operating fields. in some product models this module is attached to the cupola through a set of 4 fixing tabs which compose the plastic enclosure of the ambient light module. there is a potential risk of failure concerning the fixation of the module. one or several fixing tabs may be broken which may lead the ambient light module to detach remaining attached by its wires only. the occurrence rate observed is lower than 1% and is mainly seen in the early use of the devices.

Device

POWERLED 700
  • Model / Serial
    Model Catalog: 700 (Lot serial: NA); Model Catalog: (Lot serial: NA)
  • Product Description
    POWERLED 700
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

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