Events

Recall of PATIENT MONITOR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD..

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
    32059
  • Event Risk Class
    II
  • Event Initiated Date
    2016-07-27
  • 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
    Mindray has identified a potential for a leak to occur with the co2 module's dryline ii water trap (p/n 100-000080-00) used with the passport series patient monitor.

Device

PATIENT MONITOR
  • Model / Serial
    Model Catalog: T1 (Lot serial: 1534 and/or greater); Model Catalog: PASSPORT 17M (Lot serial: 1534 and/or greater); Model Catalog: PASSPORT 12M (Lot serial: 1534 and/or greater)
  • Product Description
    Passport 12m/17m Patient Monitors & T1 Transport monitor
  • Manufacturer
    SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD.

Manufacturer

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD.