Events

Recall of Device Recall PIIC iX Intellivue iX Information Center Software

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Electronics North America Corporation.

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
    79132
  • Event Risk Class
    Class 2
  • Event Number
    Z-0776-2018
  • Event Initiated Date
    2018-01-03
  • 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=161421
  • 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,network and communication,physiological monitors - Product Code MHX
  • Reason
    Once a surveillance station is restarted on january 1, 2018 or later, the station will be unable to perform patient discharge and transfer operations. any subsequent attempt to perform these operations will cause the station to restart, resulting in a short period of loss of monitoring at the surveillance station during such restart. until this issue can be corrected, users should avoid intentionally restarting their surveillance stations in 2018.
  • Action
    To avoid this issue, do not intentionally restart any surveillance stations that have been running normally since the new year. You may use the workflows described in attachment Alternative Workflows for PIIC iX to avoid operations that may cause the surveillance station to restart. When a patient is discharged, confirm that the patient is discharged. Philips has initiated a correction to address this issue and will provide this software update to customers with affected devices at no charge. Software updates for PIIC iX A.0x and B.0x are expected to be available by January 8th. A Philips Healthcare representative will contact customers with affected devices to arrange for correction of the issue. Contact your local Philips representative if you have a question about any device affected by this issue.

Device

Device Recall PIIC iX Intellivue iX Information Center Software
  • Model / Serial
    All PIIC iX Surveillance stations including: 866023 IntelliVue Info Center iX A.0 866117 PIIC Classic Upgrade 866389 IntelliVue Info Center iX B.0, C.0 867141 IntelliVue Info Center iX B.0 866025 IntelliVue Server IX A.0 866118 Database Server Upgrade A.0
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Domestic and Foreign
  • Product Description
    Intellivue iX Information Center Software - All PIIC iX Surveillance stations including: || 866023 IntelliVue Info Center iX A.0 || 866117 PIIC Classic Upgrade || 866389 IntelliVue Info Center iX B.0, C.0 || 867141 IntelliVue Info Center iX B.0 || 866025 IntelliVue Server IX A.0 || 866118 Database Server Upgrade A.0
  • Manufacturer
    Philips Electronics North America Corporation

Manufacturer

Philips Electronics North America Corporation
  • Manufacturer Address
    Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA