Events

Recall of Device Recall Philips Healthcare

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Healthcare 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
    59037
  • Event Risk Class
    Class 2
  • Event Number
    Z-2583-2011
  • Event Initiated Date
    2011-06-10
  • Event Date Posted
    2011-06-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-08-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100879
  • 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
    Monitor, physiological, patient (with arrhythmia detection or alarms) - Product Code MHX
  • Reason
    Speakers on the suresigns patient monitors and vital signs, failure may be identified by the display of a speaker malfunc message in the alarm message area or an audio failed message in the main screen of the device or by the absence of audible sound.
  • Action
    Philips Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated May 2011 to all affected customers. The letter identifies the products, problem, and actions to be taken. The letter states that customers may continue to use the affected products while awaiting replacement of the speaker, provided that the user routinely checks for the display of the "Speaker Malfunct." INOP. Additionally, the letter states that if the customer experience this INOP or there is no sound from the SureSigns Monitor, the customer is to remove the device from use and contact their local Philips service representative. The letter explains that Philips is completing the design for a replacement speaker assembly, which is expected to be available within 8 weeks. When available, Philips will replace the affected speaker assemblies free of charge. Customers are instructed to contact their local Philips Customer Care Center at 1-800-722-9377 if further information or support is required.

Device

Device Recall Philips Healthcare
  • Model / Serial
    Serial Number Range US11149477 - US11149503 US11149741 - US11149795 US11149798 - US11149883 US11149886 - US11149932 US11149935 - US11149959 US11149961 - US11149967 US11150078 - US11150124 US11150162 - US11150177 US11150196 - US11150307 US11150312 - US11150315 US11150336 - US11150343 US11150345 - US11150546
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution--USA (nationwide) and countries of ARAB JAMAHIRI, AUSTRIA, AUSTRALIA, BAHRAIN, BANGLADESH, BELGIUM, CANADA ,CHILE, COLOMBIA, CROATIA, CYPRUS, FRANCE, GERMANY, HUNGARY, INDIA, IRELAND, ITALY, KUWAIT, LEBANON, LIBYAN, MALAYSIA, MEXICO, NAMIBIA, NETHERLANDS, NEW ZEALAND, OMAN, PHILIPPINES, POLAND, PORTUGAL, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA ,SOUTH KOREA, SPAIN, SWITZERLAND, TAIWAN, TANZANIA, THAILAND, UNITED ARAB EMIRATES, and UNITED KINGDOM.
  • Product Description
    Philips SureSigns VM Series Patient Monitors: || VM4, VM6, VM 8: || Model Part Numbers || VM4 863063, 453564024371, 453564021961, 453564024401, 453564021971 || VM6 863064, 863065, 453564024421, 453564022001, 453564024441, 453564022041 || VM8 863066, 863068, 453564022081, 453564024461, 453564024481 || The SureSigns VS3 vital signs monitor and VM4, VM6 and VM8 patient monitors are for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSigns VS3 vital signs monitor and VM4, VM6 and VM8 patient monitors are for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.
  • Manufacturer
    Philips Healthcare Inc.

Manufacturer

Philips Healthcare Inc.
  • Manufacturer Address
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA