Events

Recall of VITAL SIGNS 300 SERIES NIBP MONITOR W/PULSE RATE/MAP AND PRINTER

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
    44082
  • Event Risk Class
    II
  • Event Initiated Date
    2009-07-09
  • 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
    Speakers in vsm300 vital signs monitor failed to produce sound. the failure of the speaker eliminates audio alarm tones for parameter violation equipment alerts or error codes as well as repetitive beeps to indicate pulses when monitoring sp02 (oximetry).

Device

VITAL SIGNS 300 SERIES NIBP MONITOR W/PULSE RATE/MAP AND PRINTER
  • Model / Serial
    Model Catalog: 5300P-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 530T0-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 530T0-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 5300P-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53NT0-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53NT0-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53000-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53000-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53ST0-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53ST0-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53STP-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53NTP-E1R (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53NTP-F1 (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: 530TP-F1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53STP-E1 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 53N0P-F1 (Lot serial:
  • Product Description
    VITAL-SIGNS MONITOR W/RATE/MAP PRINTER
  • Manufacturer
    WELCH ALLYN CANADA LIMITED

Manufacturer

WELCH ALLYN CANADA LIMITED