Events

Recall of Essenta DR Compact (Digital diagnostic 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-01094-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-10-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01094-1
  • 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
    1. the weight of the u-arm on the essenta dr compacta is counterbalanced by two parallel suspension springs in the column. when a single spring breaks, there is a risk that the safety catch mechanism may not activate due to the counteracting force of the remaining spring. as a result, the u-arm moves down uncontrollably. this was observed during reliability tests on the steel rope within the vertical carriage where one of the springs broke and the safety catch did not hold. in a post market risk assessment it was detected, the item can occur in the field by 2.5 years of operation. these 2.5 years are calculated for a worst case usage of the system.2. during in house testing it was detected that the lifetime of the wire rope for the vertical movement is significantly lower than 10 years specified in the instructions for use. if the rope breaks, the safety catch will hold the u-arm under all circumstances.
  • Action
    Philips Healthcare is replacing the vertical carriage, wire rope and Instructions for Use (IFU).

Device

Essenta DR Compact (Digital diagnostic X-Ray system)

Manufacturer

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