Events

Recall of MultiDiagnost Eleva and MultiDiagnost Eleva with Flat Detector

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-2018-RN-00342-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-04-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00342-1
  • 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
    Philips has been made aware of instances in which the table of the multidiagnost-eleva has suddenly started to tilt from 0 to 90 degrees (table arm down) with high speed. the cause of this unexpected movement is related to an issue with the fixation of the upper and lower tilt actuator. in the event the system experiences uncontrolled movements, there is a risk of injury for the patient on the table. a tilting table might also hit the user or bystander standing near the system.
  • Action
    Philips is advising they will be in contact with users to replace affected components on the upper and lower tilt actuator in the impacted systems. In the interim, users should monitor the tables for any of the following, stop use of, and contact Philips immediately if they occur: · the table height or tilt movement is not working · a cracking or snapping sound is heard during system operation. · a blockade is experienced in the table height or tilt movement during system movements. · the system is having an unexpected collision or the system had an unexpected collision in the past 2 months. · a CPR stand that obstructed the system when in use, or · any (other) unusual system behaviour beyond the normal use of the system.

Device

MultiDiagnost Eleva and MultiDiagnost Eleva with Flat Detector
  • Model / Serial
    MultiDiagnost Eleva and MultiDiagnost Eleva with Flat DetectorSystem Code Numbers: 708032, 708034, 708036, 708037, 708038Model: MD-Eleva, UD-ElevaARTG Number: 98560Philips Electronics Australia - X-ray system, diagnostic, fluoroscopic, general-purpose, stationary, digital
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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