Events

Recall of ACTIWATCH SPECTRUM PLUS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by RESPIRONICS INC..

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
    17435
  • Event Risk Class
    II
  • Event Initiated Date
    2014-02-28
  • 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
    Distributed actiwatch spectrum plus devices have exhibited battery related issues leaving the device inoperable and unable to collect data. the battery failures occur out of box or prematurely after 1 to 10 days of use. normal battery life for a fully charged battery is 50 to 60 days.

Device

ACTIWATCH SPECTRUM PLUS
  • Model / Serial
    Model Catalog: 1101894 (Lot serial: Serial number P60004); Model Catalog: 1101894 (Lot serial: Serial number P60015); Model Catalog: 1101894 (Lot serial: Serial number P60016)
  • Product Description
    ACTIWATCH SPECTRUM PLUS
  • Manufacturer
    RESPIRONICS INC.

Manufacturer

RESPIRONICS INC.
  • Manufacturer Address
    MURRYSVILLE
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    HC