Events

Recall of XN-11 MODULE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SYSMEX CANADA INC..

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
    109839
  • Event Risk Class
    III
  • Event Initiated Date
    2016-11-18
  • 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
    Sysmex america inc. (sai) has become aware through customer complaints that the computer power supply on the information processing unit (ipu) used with the sysmex xn-series xt-series and xs-series hematology analyzers shut down disabling the analyzer. the power supply has an over-voltage regulator to halt power in the presence of a power spike and prevent potential damage to the power supply and the associated device. the regulator in the power supplies within a specific serial number range were found to be more sensitive than necessary to normal power fluctuations causing the shutdown of the ipu during normal operation.

Device

XN-11 MODULE
  • Model / Serial
    Model Catalog: XN-11 (Lot serial: > 10 Lots contact MFG); Model Catalog: XS-1000I (Lot serial: > 10 lots contact MFG); Model Catalog: XT-2000I (Lot serial: > 10 lots contact MFG); Model Catalog: XN-10 (Lot serial: > 10 lots contact MFG)
  • Product Description
    XN-11 Module;XS-1000i Hematology Analyzer;XT-2000i Hematology Analyzer;XN-10 Module
  • Manufacturer
    SYSMEX CANADA INC.

Manufacturer

SYSMEX CANADA INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Sysmex Corp.
  • Source
    HC