BEUDAMED
    FDA Recall Terminated

    "***Assembled for Invivo Corporation 12501 Research Parkway Orlando FL 32826***Made in U.S.A.***MRI Patient Monitoring System Model 865214***Use only with Model 989803169201 Power Adapter***REF 453564155341***SN US11401652***". Note: REF 453564155341, REF 453564181201, and 453564180091 are subject to recall. REF is the firms Service Number which identifies the device. Product Usage The Expression MRI Patient Monitoring System is intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures. The Patient Monitoring System also provides signals for synchronization of the MR scanner.

    Recall: Z-0106-2012 · Initiated August 30, 2010

    Recall

    Recall Number
    Z-0106-2012
    Event Number
    58984
    Firm
    Invivo Corporation
    FEI Number
    1051786
    Product Code
    MWI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 30, 2010
    Posted
    October 25, 2011
    Terminated
    November 15, 2012
    Address
    12151 Research Pkwy, Suite 200, Orlando, FL, 32826-3222

    Description

    "***Assembled for Invivo Corporation 12501 Research Parkway Orlando FL 32826***Made in U.S.A.***MRI Patient Monitoring System Model 865214***Use only with Model 989803169201 Power Adapter***REF 453564155341***SN US11401652***". Note: REF 453564155341, REF 453564181201, and 453564180091 are subject to recall. REF is the firms Service Number which identifies the device. Product Usage The Expression MRI Patient Monitoring System is intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures. The Patient Monitoring System also provides signals for synchronization of the MR scanner.

    Reason

    Philips Invivo Corporation of Orlando, FL is recalling their Expression MRI Patient Monitoring System. During transport of the system's cart with a docked Display Controller Unit (DCU), a front caster (wheel) may become loose and fall off causing the cart to become unbalanced and fall.

    Action

    Philips Invivo Corporation issued a Field Safety Notice "URGENT - MEDICAL DEVICE RECALL" letter to all affected customers notifying them that the Expression MRI Patient Monitoring System could pose a risk for patients and users. The notice identifies the following: what the problem is and under what circumstances it can occur; the actions that should be taken by the user in order to prevent risks for patients or users and the actions planned by Philips Invivo to correct the problem. This notice contains important information for the continued safe and proper use of the equipment and customers were advised to retain a copy with the equipment Instruction for Use. Customers were instructed to contact Philips Invivo Customer Support at (877) 468-4861 (option 1, then option 3) for questions or support concerning this issue.

    Distribution

    Worldwide Distribution - USA (nationwide) including the states of: AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI., SC, SD, TN, TX, VA, WA, and WI and the countries of: Australia, Austria, Canada, Denmark, Germany, Israel, Malaysia, Netherlands, Norway, Singapore, Spain, Switzerland and, United Kingdom.

    Quantity

    285 units