Events

Recall of Philips Healthcare SureSigns VSi/VS2

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
    62865
  • Event Risk Class
    Class 2
  • Event Number
    Z-2303-2012
  • Event Initiated Date
    2012-08-15
  • Event Date Posted
    2012-08-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-03-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111900
  • 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
    System, measurement, blood-pressure, non-invasive - Product Code DXN
  • Reason
    Philips suresigns vsi/vs2+ patient monitors may not be properly secured and may fall from the wall mount.
  • Action
    Philips sent an "URGENT- MEDICAL DEVICE CORRECTION" letter dated August 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers using the VSi/VS2+ with the GCX wall mount are instructed to complete and fax a Customer Reply Wall Mount Order Card to the Business Unit or Key Market indicating the number of wall mounts in use. Upon receipt of the Customer Reply Wall Mount Order Card, Philips will send a replacement of the mounting hardware. Customers should contact their local Philips representative for questions regarding this recall.

Device

Philips Healthcare SureSigns VSi/VS2
  • Model / Serial
    Serial Number Range CN14800101-CN14801360  CN21201362-CN21202440, CN21202525, SP13701043, USPP101007
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, DENMARK, EL SALVADOR, FRANCE, GERMANY, ICELAND, INDIA, IRELAND ISRAEL, ITALY, JORDAN, KENYA, LEBANON, MALAYSIA,NAMIBIA NETHERLANDS, NORWAY, POLAND, PORTUGAL, RWANDA SAUDI ARABIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN SWITZERLAND, UNITED ARAB EMIRATES, and UNITED KINGDOM.
  • Product Description
    Philips SureSigns VSi/VS2+ patient monitors || Model Part Numbers || VSi/ 863275, 863276, 863277, || VS2+ 863278, 863279. || The SureSigns VS2+ vital signs monitor is 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. The SureSigns VSi vital signs monitor is for measurement 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