BEUDAMED
    FDA Recall Terminated

    The device's marketing brochure states: "IntelliVue M3150 Information Center...Philips Medical Systems". The beige-colored PAS-210 external speakers can be identified by their use of DB15-to-3.5 mm mini-phone jack cable (Agispec-081Y-4 or Agispec-081-6) to connect to the rp5700 PC. Indicated for central monitoring of multiple adult, pediatric, and neonatal patients.

    Recall: Z-0034-2011 · Initiated November 21, 2008

    Recall

    Recall Number
    Z-0034-2011
    Event Number
    50215
    Firm
    Philips Medical Systems North America Co. Phillips
    FEI Number
    1000524572
    Product Code
    DSI
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    November 21, 2008
    Posted
    October 8, 2010
    Terminated
    October 12, 2010
    Address
    22100 Bothell Everett Hwy, Bothell, WA, 98021-8431

    Description

    The device's marketing brochure states: "IntelliVue M3150 Information Center...Philips Medical Systems". The beige-colored PAS-210 external speakers can be identified by their use of DB15-to-3.5 mm mini-phone jack cable (Agispec-081Y-4 or Agispec-081-6) to connect to the rp5700 PC. Indicated for central monitoring of multiple adult, pediatric, and neonatal patients.

    Reason

    Potential for Internal Sound Amplifier to malfunction which could delay treatment.

    Action

    On 11/20/08, Philips began sending the URGENT-Medical Device Correction letter to their consignees via e-mails. On 11/21/08, the firm sent out the recall letter via United State Postal Service. The letter states the affected device as Philips IntelliVue Information Centers, running on the HP rp5700 PC platform equipped with an active speaker solutions using a DB-15 to 3.5 mm cable set. The consignees are advised to ensure that the audible alarm system is clear, free of noise and distortion and adjustable to different sound levels which is explained in p. 5-47 "Adjusting Alarm Tone Volume" of IntelliVue of the Instruction for Use, Release K Manual, supplied with the hardware, Philips Part Number 453564062301. Consignees can call Philips Healthcare Customer Care Service Center at 1-800-722-9377, #3, #1 and reference FCO 99862012.

    Distribution

    Nationwide Distribution

    Quantity

    424 units in US.