BEUDAMED
    FDA Recall Terminated

    The product is an isolation transformer, an accessory to Computed Tomography Scanner. It consists of electronic circuitry enclosed in a metal case. According to Philips Medical Systems, the metal case is manufactured from self-extinguishing materials. The unit is labeled in part, "Power Conditioner *** Part Number 4450028-XX *** Frequency: *** S/N: *** Rev: *** MFG date: *** INPUT RATINGS *** Model: MCT 100/480 ISOTRAN PLUS *** OUTPUT RATINGS *** MEDICAL POWER SUPPLY UL *** TEAL Electronics Corporation, San Diego, California ***".

    Recall: Z-1234-2007 · Initiated April 27, 2007

    Recall

    Recall Number
    Z-1234-2007
    Event Number
    44721
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    April 27, 2007
    Posted
    September 13, 2007
    Terminated
    March 2, 2012
    Address
    595 Miner Road, Cleveland, OH, 44143-2131

    Description

    The product is an isolation transformer, an accessory to Computed Tomography Scanner. It consists of electronic circuitry enclosed in a metal case. According to Philips Medical Systems, the metal case is manufactured from self-extinguishing materials. The unit is labeled in part, "Power Conditioner *** Part Number 4450028-XX *** Frequency: *** S/N: *** Rev: *** MFG date: *** INPUT RATINGS *** Model: MCT 100/480 ISOTRAN PLUS *** OUTPUT RATINGS *** MEDICAL POWER SUPPLY UL *** TEAL Electronics Corporation, San Diego, California ***".

    Reason

    The TEAL Power Conditioning units may fail and result in the unit emitting fire and/or smoke. Note: the TEAL Power Conditioning Unit has the potential to fail when the scanner that is attached to the TEAL is powered and in use as well as when not in use.

    Action

    On 9/04/2007, Philips Medical Systems (PMS) sent a letter via courier to all affected customers. The letter notified customers about the failures of the TEAL power conditioner and the possible emisson of fire and/or smoke from the units. In addition, the letter notes that PMS implemented a Field Change Order in May, 2007 that directs onsite repair of all affected units by PMS service technicians.

    Distribution

    Worldwide, including, USA, Canada, China, Italy, Russia, Brazil, Belgium, Germany, Austria, Australia, Netherlands, France, Korea, Denmark, Israel, England, Argentina, Mexico, Spain, Yemen, Greece, Egypt, Japan, UAE, & Chile.

    Quantity

    491