Events

Recall of Device Recall Philips IntelliVue Clinical Information Portfolio

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
    58182
  • Event Risk Class
    Class 2
  • Event Number
    Z-2175-2011
  • Event Initiated Date
    2011-03-16
  • Event Date Posted
    2011-05-10
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98612
  • 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
    patient data system - Product Code NSX
  • Reason
    Edits to an order can result in unintended scheduled interventions and a patient may receive additional interventions or medication doses that are not intended.
  • Action
    Philips Healthcare notified accounts on 3/16/11 via the Urgent Medical Device Correction Notification. Customer notifications in the United States will be delivered via UPS. Customer notifications outside the US will be managed by Philips representatives in each affected geography. Customers will be asked to follow the guidelines in the Action to be taken by Customer/User section of the Urgent Medical Device Correction Notice until they receive their software correction. The correction will be in the form of a software upgrade and will be performed by Philips service personnel. All customers potentially affected by this issue will receive the software correction as part of the field action.

Device

Device Recall Philips IntelliVue Clinical Information Portfolio
  • Model / Serial
    versions D.03, E.0, or E.01 of the software
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA, Canada, Australia, Austria, Belgium, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Kenya, Latvia, Malaysia, Netherlands, Norway, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, and United Kingdom.
  • Product Description
    Philips IntelliVue Clinical Information Portfolio software as follows: || 865047 IntelliVue Clinical Information Portfolio Release D.03; 865209 IntelliVue Clinical Information Portfolio Release E.0 and E.01; 865300 IntelliVue Clinical Information Portfolio NICU Link
  • 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