Events

Recall of MultiDiagnost Eleva and MultDiagnost Eleva with Flat Detector (diagnostic fluoroscopic 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-2016-RN-00943-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-07-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00943-1
  • 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
    The two bolts that attach the clamping plate to the lateral shaft may break. this may cause the c-arm to float freely. depending on the orientation of the free-floating c-arm and any other forces applied to it, the c-arm could move laterally forward, slide out of its bearings and then possibly sag. the sagging c-arm can strike a patient or operator. however, the probability of this occurring is rare. there have been no reports of injury associated with this event.
  • Action
    Philips is advising users to be aware of the issue. If the C-arm moves in an unexpected manner, users should contact Philips immediately. Philips will be implementing a repair of the C-arm as a permanent correction. This action has been closed-out on 28/06/2017.

Device

MultiDiagnost Eleva and MultDiagnost Eleva with Flat Detector (diagnostic fluoroscopic x-ray system)
  • Model / Serial
    MultiDiagnost Eleva and MultDiagnost Eleva with Flat Detector (diagnostic fluoroscopic x-ray system)MultiDiagnost ElevaProduct Code: 708032MultiDiagnost Eleva with Flat DetectorProduct Code: 708034MultiDiagnost ElevaProduct Code: 708036MultiDiagnost Eleva with Flat DetectorProduct Code: 708037 MultiDiagnost Eleva with Flat DetectorProduct Code: 708038ARTG Number: 98560
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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