Recall of ESSENTA DR COMPACT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PHILIPS ELECTRONICS LTD..

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
    62535
  • Event Risk Class
    II
  • Event Initiated Date
    2010-09-27
  • Event Country
  • 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
    During factory internal testing of this device philips identified wear of the main steel cable which supports the u-shaped swivel arm. consequently the cable might break prematurely outside of the specifications set for the cable (lifetime 50000 cycles). if the cable breaks the built in safety catch may not adequately prevent the unit from falling down.

Device

  • Model / Serial
    Model Catalog: 9890 010 88201 (Lot serial: 461313/SN10000024)
  • Product Description
    ESSENTA DR COMPACT
  • Manufacturer

Manufacturer

  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
  • Source
    HC