Events

Recall of Essenta DR Compact (General purpose X-ray system)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Philips Electronics Australia 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
    RC-2012-RN-00787-3
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-08-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00787-3
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Three issues requiring correction have been identified by the manufacturer:1. during reliability tests on the steel rope, one of the springs broke and the safety catch did not hold. the safety catch mechanism does not activate due to the counteracting force of the remaining spring. as a consequence the u-arm moves down uncontrolled. the manufacturer has identified that this can occur in the field earliest after 2.5 years of operation. these 2.5 years are calculated for a worst case usage of the system. 2. during installation all 3 screws for one sib chain wheel were found loose. if all 3 screws of one of these wheels loosen completely, the detector carriage and/or the tube carriage can move down uncontrolled until stopped by the corresponding end stop.3. during in-house testing it was detected that the life time of the wire rope is significantly lower than the specified 10 years. the replacement of the wire rope every 3 years is required.
  • Action
    Philips is urging customers to contact them if they have any concerns and is replacing the vertical carriage, wire rope, SID chain wheels and Instructions for Use.

Device

Essenta DR Compact (General purpose X-ray system)

Manufacturer

Philips Electronics Australia Ltd
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DHTGA