BEUDAMED
    FDA Recall Terminated

    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

    Recall: Z-2175-2011 · Initiated March 16, 2011

    Recall

    Recall Number
    Z-2175-2011
    Event Number
    58182
    Firm
    Philips Healthcare Inc.
    FEI Number
    1218950
    Product Code
    NSX
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 16, 2011
    Posted
    May 10, 2011
    Terminated
    August 13, 2020
    Address
    3000 Minuteman Road, Andover, MA, 01810

    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

    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.

    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.

    Quantity

    387 units