Events

Recall of BATTERY

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
    19701
  • Event Risk Class
    II
  • Event Initiated Date
    2017-05-29
  • 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 received two (2) reports that the battery pack for the tl transport monitor /module overheated forming a small melted cavity in the outer housing. in both reports the battery emitted smoke and was hot to the touch. in one (1) report a small flame was noted on the battery surface.

Device

BATTERY
  • Model / Serial
    Model Catalog: (Lot serial: DS 17 G 08 XXXXX); Model Catalog: (Lot serial: DS 17 G 04 XXXXX); Model Catalog: (Lot serial: DS 10 X XX XXXXX); Model Catalog: (Lot serial: DS 17 E XX XXXXX); Model Catalog: (Lot serial: DS 17 F XX XXXXX)
  • Product Description
    T1 Transport Monitor/Module Battery Pack
  • Manufacturer
    SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD.

Manufacturer

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD.