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
    68463
  • Event Risk Class
    II
  • Event Initiated Date
    2014-05-28
  • 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
    The distributed actiwatch spectrum plus devices were originally classified by respironics as a class 1 rule 12 medical device using the classifications rules for medical devices found in schedule 1 of the medical device regulations. as indicated by health canada the device was deemed to be a class ii device requiring a license prior to product distribution.

Device

ACTIWATCH SPECTRUM PLUS
  • Model / Serial
    Model Catalog: 1101894 (Lot serial: n/a)
  • Product Description
    ACTIWATCH SPECTRUM PLUS
  • Manufacturer
    RESPIRONICS INC.

Manufacturer

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