BEUDAMED
    FDA Recall Terminated

    PCR Eleva. The marketing brochure is labeled in parts: "Philips Medical Systems is part of Royal Philips Electronics... www.medical.philips.com... Philips Medical Systems Nederland B.V". Provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images.

    Recall: Z-1019-2011 · Initiated December 23, 2008

    Recall

    Recall Number
    Z-1019-2011
    Event Number
    57558
    Firm
    Philips Medical Systems North America Co. Phillips
    FEI Number
    1000524572
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 23, 2008
    Posted
    February 4, 2011
    Terminated
    August 25, 2011
    Address
    22100 Bothell Everett Hwy, Bothell, WA, 98021-8431

    Description

    PCR Eleva. The marketing brochure is labeled in parts: "Philips Medical Systems is part of Royal Philips Electronics... www.medical.philips.com... Philips Medical Systems Nederland B.V". Provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images.

    Reason

    There is a risk of selecting the wrong patient, when patient is selected in the patient list and the examination tab pressed with background query are running at the same time.

    Action

    On 1/30/2009, Philips began sending out URGENT-Device Correction PCR Eleva notifications to their consignees. The consignees were informed of the hazards as when a patient is selected in patient list and examination tab pressed with background query running at the same time, there would be a risk that the wrong patient is selected. The firm issued the Field Corrective Order (FCO) 73200029 to their representative to correct the problem. The corrective action would be a software upgrade that resolve the issue. All consignees can contact Philips Call Center at 800-722-9377, #5, #2 and reference "FCO 73200029" with any questions.

    Distribution

    Nationwide Distribution -- USA, including states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WI, WV, and WY and to LANDSTUHL ARMY BASE, APO in United Arab Emirates.

    Quantity

    686 units