Events

Recall of VITROS 5600 INTEGRATED SYSTEM - INSTRUMENT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ORTHO-CLINICAL DIAGNOSTICS.

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
    95395
  • Event Risk Class
    II
  • Event Initiated Date
    2016-02-02
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Ortho clinical diagnostics has initiated this recall notification due to a possibility of misconfigured electrical wiring in the power system on the vitros 5600 integrated system. this creates a situation where an individual module intended to be shut off will remain on if only the associated power cord is unplugged. note there are two power cords per vitros 5600 system. normal use maintenance and troubleshooting on vitros 5600 systems will not expose an operator to electrical hazards as a result of this issue. the electrical wires are located in an area that is intended to be accessed only by ortho-trained service representatives. 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 SYSTEM - INSTRUMENT
  • Model / Serial
    Model Catalog: 680 2413 (Lot serial: > 10 contact manufacturer)
  • Product Description
    VITROS 5600 Integrated System
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS