Recall of WELCH ALLYN PIC 50

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

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
    27314
  • Event Risk Class
    II
  • Event Initiated Date
    2006-11-09
  • Event Country
  • 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
    There's a higher proportion of complaints associated with intermittent connection between a flat flex cable and its connector on the ecg circuit board leading to communication errors.

Device

  • Model / Serial
    Model Catalog: 971083E (Lot serial: 82667); Model Catalog: 971084E (Lot serial: 82667); Model Catalog: 971081E (Lot serial: 82667); Model Catalog: 971084E (Lot serial: 82662); Model Catalog: 971083E (Lot serial: 82662); Model Catalog: 971082E (Lot serial: 82662); Model Catalog: 971081E (Lot serial: 82662); Model Catalog: 971084E (Lot serial: 82631); Model Catalog: 971083E (Lot serial: 82631); Model Catalog: 971082E (Lot serial: 82631); Model Catalog: 971081E (Lot serial: 82631); Model Catalog: 971084E (Lot serial: 82630); Model Catalog: 971083E (Lot serial: 82630); Model Catalog: 971082E (Lot serial: 82630); Model Catalog: 971081E (Lot serial: 82630); Model Catalog: 971084E (Lot serial: 82025); Model Catalog: 971083E (Lot serial: 82025); Model Catalog: 971082E (Lot serial: 82025); Model Catalog: 971081E (Lot serial: 82025); Model Catalog: 971084E (Lot serial: 81105); Model Catalog: 971083E (Lot serial: 81105); Model Catalog: 971082E (Lot serial: 81105); Model Catalog: 971081E (Lot serial: 81105); Model Catal
  • Product Description
    WELCH ALLYN PIC 50
  • Manufacturer

Manufacturer