Events

Recall of Philips Telemonitoring System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems.

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
    49402
  • Event Risk Class
    Class 2
  • Event Number
    Z-0100-2009
  • Event Initiated Date
    2008-09-11
  • Event Date Posted
    2008-10-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73259
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Oximeter - Product Code DQA
  • Reason
    Multiprint report may contain incorrect vital data for patients.
  • Action
    Philips contacted customers by sending an Urgent Medical Device Correction Notification on 9/11/08. Letters to customers sent via certified mail and receipt of delivery will be tracked. Customers are asked to follow the Action To Be Taken By Customer/User section of the Urgent Medical Device Correction Notification. This section instructs users to allow the upgrade of the software upon logging in to the system. Contact Philips at 1-866-246-7316 for assistance.

Device

Philips Telemonitoring System
  • Model / Serial
    M3811B software revision identified as Build 1.1.2.11d, B.02.07.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    M3811B Philips Telemonitoring Clinical Review Software part of Philips Telemonitoring System, M3810A, software revision identified as Build 1.1.2.11d, B.02.07. Prescriptive medical device used to automatically collect and transmit medical information (weight, blood pressure, non-diagnostic ECG) over phone lines between provider and patient.
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • Manufacturer Address
    Philips Medical Systems, 3000 Minuteman Road, Andover MA 01810
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA