BEUDAMED
    FDA Recall Terminated

    NT Intera Magnetic Resonance Image System

    Recall: Z-1488-04 · Initiated August 20, 2004

    Recall

    Recall Number
    Z-1488-04
    Event Number
    29966
    Firm
    Philips Medical Systems Sales & Service Region No. America
    FEI Number
    1000524572
    Product Code
    KRP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 20, 2004
    Posted
    September 29, 2004
    Terminated
    February 9, 2006
    Address
    22100 Bothell Everett Hwy, Bothell, WA, 98021

    Description

    NT Intera Magnetic Resonance Image System

    Reason

    Potential for patient burn

    Action

    On 8/20/04 the firm issued a letter, via certified return receipt. The letter warned of the potential for patient discomfort and burns. An addendum providing additional information regarding cable positioning was included with the letter.

    Distribution

    Units distributed to medial facilities and hospitals throughout the U.S.

    Quantity

    156 devices