Events

Safety Alert for EasyDiagnost (70642, 70643, 706030, 706031, and 706032)

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
    2012-08-06
  • Event Date Posted
    2012-08-06
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120806a.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 easydiagnost medical device manufacturer, philips healthcare, has initiated a field safety corrective action for philips easydiagnost (70642, 70643, 706030, 706031, and 706032). only units that have had the inclination switch replaced during service are affected. according to the manufacturer, an inclination switch in the stand may have been mounted incorrectly during system service. there is a potential that a significant compression force could be exerted on a patient if, due to a combination of software and hardware errors, the inclination switch is not activated and the tilting movement is not immediately stopped. this severe squeezing has the potential to result in serious harm or injury. however, there is a very low probability that this combination of errors would occur. the manufacturer advised users to refer to the ifu for actions taken in preventing unintended compression by inserting the "compression stop" in the highest position. a field service engineer will be dispatched to verify if a switch was installed properly, and in the event it was not installed properly s/he will reinstall it properly. according to the local supplier, the affected devices were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 6 august 2012.

Device

EasyDiagnost (70642, 70643, 706030, 706031, and 706032)
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Philips EasyDiagnost
  • Manufacturer
    Philips Healthcare

Manufacturer

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