Events

Field Safety Notices about VITROS® 5600 Integrated Systems

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Ortho Clinical Diagnostics.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    The electrical wires are located in an area that is intended to be accessed only by an ortho-trained service representative. normal use, maintenance and troubleshooting on your vitros® 5600 system will not expose an operator to electrical hazards as a result of this issue. if a system has the incorrect wire configuration, it is possible that if the power to an individual module is intended to be shut off, it will remain on. however, there is no risk to ortho-trained service personnel if they follow normal procedures and power off the appropriate module or the vitros® 5600 system as a whole prior to working on a component. .

Device

VITROS® 5600 Integrated Systems
  • Model / Serial
    VITROS® 5600 Integrated System 6802413 6802915 10758750002740 10758750007110
  • Manufacturer
    Ortho Clinical Diagnostics

Manufacturer

Ortho Clinical Diagnostics