Events

Recall of Device Recall Philips

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
    49005
  • Event Risk Class
    Class 3
  • Event Number
    Z-2369-2008
  • Event Initiated Date
    2008-07-22
  • Event Date Posted
    2008-09-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72508
  • 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
    Software: if weight limits edited, values will return to default values that were deleted.
  • Action
    Affected customers will receive the Urgent Medical Device Correction notification on 7/22/08 via certified mail. Delivery receipt will be tracked. The Urgent Medical Device Correction notification instructs customers to verify that daily and weekly weight limits are set or not set as intended while they await the correction, which will come in the form of a new version of software and will simultaneously update all systems. Philips has corrected the software defect and is in the process of validating the correction and releasing the corrected software as part of a scheduled release. If further information or support is needed, customers should contact the Telehealth Customer Service Line at 1-866-246-7316.

Device

Device Recall Philips
  • Model / Serial
    Software Revision: B.02.07
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Philips Telemonitoring System Software (M3811B) used with || Philips Telemonitoring System (M3810B) || Revision: 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