Events

Recall of VITAL SIGNS 300 SERIES NIBP MONITOR AND NELLCOR SPO2

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
    30596
  • Event Risk Class
    II
  • Event Initiated Date
    2009-12-04
  • 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 firm distributed a field correction letter notifying users to check that the audio function is working each time they use the device with a label for each unit and new updated dfus.

Device

VITAL SIGNS 300 SERIES NIBP MONITOR AND NELLCOR SPO2
  • Model / Serial
    Model Catalog: 53S00-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53N00-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53N00-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53N0P-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53S0P-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53S0P-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53S00-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53N0P-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53NTP-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 530TP-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53STP-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 530TP-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53NTP-E1R (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53STP-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53NTP-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53ST0-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53NT0-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53NT0-F1 (Lot serial:
  • Product Description
    VITAL SIGNS 300 MONITOR/NELLCOR SPO2
  • Manufacturer
    WELCH ALLYN CANADA LIMITED

Manufacturer

WELCH ALLYN CANADA LIMITED