Events

Recall of DIGITAL BLOOD PRESSURE MONITOR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PHILIPS ELECTRONICS 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
    71445
  • Event Risk Class
    III
  • Event Initiated Date
    2016-10-26
  • 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
    A&d may have shipped blood pressure monitors that were not labeled for use with small cuff. the device is intended to be used with arm sizes from 5.1 inches to 17.7 inches or small cuffs (6.3-9.4") medium cuffs ( 9.4-14.2") and large cuffs (14.2-17.7"). for optimal comfort the manufacturer adjusts the exhaust valve for the devices to be used with a small cuff. in doing so the manufacturer may have not provided clear labeling on the front of these devices to indicate they have been adjusted for small cuff use. additionally some devices may have been labeled "adjusted for small cuffs" but may have been equipped with a medium cuff.

Device

DIGITAL BLOOD PRESSURE MONITOR
  • Model / Serial
    Model Catalog: UA-767PBT-CI (Lot serial: 5150402416); Model Catalog: UA-767PBT-CI (Lot serial: 5150402411)
  • Product Description
    Digital Pressure Monitor
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    HC