Events

Safety Alert for multidiagnost eleva fd

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Philips Healthcare.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2015-01-21
  • Event Date Posted
    2015-01-21
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150121a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: philips healthcare multidiagnost eleva fd medical device manufacturer, philips healthcare, has issued a field safety notice concerning multidiagnost eleva fd [product code: 708037]. in the md eleva system, software license keys are used to enable particular functionality. the manufacturer has discovered that in software release r6.1.1sp2 and r6.1.2 intermittently part of the software keys are not loaded: the license key for spectral filter the license key for full table tilt range if the license key for spectral filter is not loaded, then a higher than expected patient dose will occur in low dose mode for positioning of the patient, positioning of the x-ray beam, and/or in situations in which the x-ray image has lots of contrast. if the license key for full table tilt range is not loaded, then the table tilt range will be restricted. in such a case not all desired image projections are possible. the manufacturer will perform software upgrade for affected units before may 2015. according to the local supplier, the affected product is distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 21 january 2015.

Device

multidiagnost eleva fd
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Philips Healthcare MultiDiagnost Eleva FD
  • Manufacturer
    Philips Healthcare

Manufacturer

Philips Healthcare
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DH