Events

Safety Alert for allura xper systems - allura xper fd10 , allura xper fd10/10 , allura xper fd20, allura xper fd20/10, allura xper fd20/20 and allura cv20

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
    2011-08-04
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20110804a.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
    Field safety notice: philips allura xper systems - allura xper fd10 (f/c), allura xper fd10/10 (incl. or table), allura xper fd20, allura xper fd20/10, allura xper fd20/20 and allura cv20 philips healthcare has issued a field safety notice to the customers of allura xper systems. investigation of field problems on the allura xper systems showed that there is a problem related to the harddisk firmware. the hard disk drive itself is working fine but the used firmware suffers from an incorrect incrementing smart counter. this might result in a very high “raw read error” count which will lead in a so called “smart trip” and subsequently will take the hard disk drive offline. consequently the system might intermittently freeze. this can vary from several seconds up to one minute. if during a procedure the system intermittently freezes for several seconds and up to one minute, the system does not generate x-ray anymore and no geometry movement is possible during this period of time. if this happens during a critical phase in a procedure this might lead to a disturbance in the procedure and a possible injury to the patient. this intermittent image freeze / system freeze is not foreseeable or recognizable by the user. the manufacturer recommended customers not to reboot or take any other actions until the system proceeds on its own, because this could slowdown the systems automatically recovery. the manufacturer will provide users a cd with the correct firmware and an installation procedure to implement the corrective actions. according to the local supplier, hong kong is affected. the local supplier is following up the issue with its customers. if you are in possession of the affected product, please contact your supplier (hotline: 2821-5473) for necessary actions.

Device

allura xper systems - allura xper fd10 , allura xper fd10/10 , allura xper fd20, allura xper fd20...
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: [4 Aug 2011] Philips Allura Xper Systems - Allura Xper FD10 (F/C), Allura Xper FD10/10 (incl. OR table), Allura Xper FD20, Allura Xper FD20/10, Allura Xper FD20/20 and Allura CV20
  • Manufacturer
    Philips Healthcare

Manufacturer

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