Events

Recall of SURESIGNS VM8

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
    109980
  • Event Risk Class
    II
  • Event Initiated Date
    2009-11-04
  • 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
    Philips' suresigns patient monitors vital signs monitors and vital signs viewers allow the device speaker volume to be adjusted by the user. philips healthcare has determined that in rare instances the continued use of these speakers at their maximum volume setting may result in the premature failure of the internal speaker. if the device speaker fails during use this may contribute to a delay in treatment of a patient.

Device

SURESIGNS VM8
  • Model / Serial
    Model Catalog: (Lot serial: US90328668); Model Catalog: (Lot serial: US63506498); Model Catalog: (Lot serial: US91929777); Model Catalog: (Lot serial: US72010335); Model Catalog: (Lot serial: US63507187); Model Catalog: (Lot serial: US74917316); Model Catalog: (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: (Lot serial: US80501179); Model Catalog: (Lot serial: US80501178); Model Catalog: (Lot serial: US74101045); Model Catalog: (Lot serial: US80501208)
  • Product Description
    SURESIGNS VM8 PATIENT MONITOR
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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