Events

Recall of Device Recall IntelliVue

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
    51979
  • Event Risk Class
    Class 2
  • Event Number
    Z-1654-2009
  • Event Initiated Date
    2009-05-05
  • Event Date Posted
    2009-07-07
  • 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=81813
  • 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 collection, storage, and management system - Product Code DXJ
  • Reason
    Error in therapy scheduling: if scheduled orders are documented and edited prior to the orders' original schedule time, icip can create a second instance of the same order marked as pending. a second instance of an order may result in a patient receiving duplicate therapy or patients may not receive their scheduled therapies.
  • Action
    Philips notified customers by Urgent Medical Device Correction Notification letter on May 6, 2009. The 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 corrections. The corrections will be in the form of software upgrades and will be performed by Philips service personnel. On May 27, 2009, Philips issued the second Urgent Medical Device Correction notification. While customers await the correction of their devices, customers are given the following instructions: Clinicians should not rely solely on the worklist within lCIP to determine actionable orders for the patient until their software is upgraded. Clinical users should always use the medication administration record (MAR) and the administration record in determining the care their patients receive in addition to the critical care worklist.

Device

Device Recall IntelliVue
  • Model / Serial
    Serial Numbers: US73900100 US73900101 US73900102 US73900103 US73900104 US73900105 US73900106 US73900107 US73900108 US73900109 US73900110 US73900111 US73900112 US73900113 US73900114 US73900115 US73900116 US73900117 US73900118 US73900119 US73900120 US73900121 US73900122 US73900123 US73900124 US73900125 US73900126 US73900127 US73900128 US73900129 US73900130 US73900131 US73900132 US73900133 US73900134 US73900135 US73900136 US73900137 US73900138 US73900140  US73900141 US73900142 US73900143 US73900144 US73900145 US73900146 US73900147 US73900148 US73900149 US73900150 US73900151 US73900153 US73900154 US73900155 US73900156 US73900157 US73900158 US73900159 US73900160 US73900161 US73900162 US73900163 US73900164 US73900165 US73900166 US73900167 US73900168 US73900169 US73900170 US73900171 US73900172 US73900173 US73900174 US73900175 US73900176 US73900177 US73900178 US73900179 US73900180 US73900181 US73900182 US73900183 US73900184 US73900185 US73900186 US73900187 US73900188 US73900189 US73900190 US73900191 US73900192 US73900193 US73900194 US73900195 US73900197 US73900198 US73900199 US73900200 US73900201 US73900202, and  US73900203.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution, including USA, Australia, Belgium, China, Denmark, France, Germany, Ireland, Italy, Kenya, Malaysia, Netherlands, Singapore, Spain, Switzerland, Taiwan, UAE, and UK.
  • Product Description
    Philips IntelliVue Clinical Information Portfolio || Software Version D.0, for patient data collection, storage, and management.
  • 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