Events

Recall of ADVANTX LCLP+ BI PLANE CARDIAC SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE).

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
    15935
  • Event Risk Class
    II
  • Event Initiated Date
    2008-07-31
  • 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
    The lcd monitor support may disengage from its arm and fall on the table. incorrect cable routing may cause the ecg monitor power cable to be damaged. potential for short circuit sparks & electric shock.

Device

ADVANTX LCLP+ BI PLANE CARDIAC SYSTEM
  • Model / Serial
    Model Catalog: 2168678-3 (Lot serial: 208/60218 704/20006); Model Catalog: 2124818 (Lot serial: 1103/00001); Model Catalog: S1838JK (Lot serial: 1203/00008 0304/10063); Model Catalog: S1838JK (Lot serial: 00000452849BU300000524113BU8); Model Catalog: 2124818 (Lot serial: S/N 704/20021 504/10005); Model Catalog: S18741AM (Lot serial: 0604/20097 1203/00031); Model Catalog: S18741AM (Lot serial: 00000112438VE7 00000460566BU3); Model Catalog: S18741AM (Lot serial: 1203/00030 1203/00034); Model Catalog: S18741AM (Lot serial: 0304/10068 00000469393BU3); Model Catalog: S18741AM (Lot serial: 304110070 00000536832BU1); Model Catalog: S18751AM (Lot serial: 1207/60204 507/50957); Model Catalog: S18751AM (Lot serial: 1007/61039 00000524145BU0); Model Catalog: S18751AM (Lot serial: 1007/61038 1005/40433); Model Catalog: S18751AM (Lot serial: 1005/40435); Model Catalog: S18751AM (Lot serial: 00000452927BU7 907/6010)
  • Product Description
    ADVANTIX LCLP+ BI PLANE CARDIAC SYSTEM
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)