BEUDAMED
    FDA Recall Terminated

    Philips Expression Information Portal (IP5) Model 865471. The IP5 is intended to be used as a secondary display control unit for the Expression MRI Patient Monitoring System and the Expression MR200 MRI Patient Monitoring System.

    Recall: Z-2867-2016 · Initiated September 14, 2014

    Recall

    Recall Number
    Z-2867-2016
    Event Number
    74296
    Firm
    Invivo Corporation
    FEI Number
    1051786
    Product Code
    MWI
    Status
    Terminated
    Root Cause
    Software in the Use Environment
    Initiated
    September 14, 2014
    Terminated
    December 14, 2016
    Address
    12151 Research Pkwy, Ste 200, Orlando, FL, 32826-3286

    Description

    Philips Expression Information Portal (IP5) Model 865471. The IP5 is intended to be used as a secondary display control unit for the Expression MRI Patient Monitoring System and the Expression MR200 MRI Patient Monitoring System.

    Reason

    Frozen Display Numerics and Disabled Menu Keys after extended run time. This customer notification was sent August 22, 2014.

    Action

    A recall notification letter was sent to hospitals who purchased the recalled product via UPS March 2014. The letter instructed users to power cycle the IP5 unit every day. This is done by pressing the power button on the side of the unit. Customers were instructed to communicate the recall to all those subject and to attach an addendum to the IP5 Instructions for Use. The firm advised customers to call their Philips representative, option 1, then option 2, if they had any questions or concerns.

    Distribution

    Worldwide distribution. US nationwide, Australia, Austria, Denmark, France, Germany, Iceland, Ireland, Italy, Netherlands, Norway, Poland, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, and England

    Quantity

    639 units