BEUDAMED
    FDA Recall Terminated

    Respiratory Gating System, Catalog #NPTA540, Model #4535 674 26701, which includes: Pulmonary digital assembly kit and Pulmonary toolkit oncology Pro available on the following GEMINI PET/CT systems: GEMINI GXL 16 slice configuration, Model Number: 4535 679 75691.

    Recall: Z-0286-2010 · Initiated November 24, 2008

    Recall

    Recall Number
    Z-0286-2010
    Event Number
    50135
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    November 24, 2008
    Posted
    November 17, 2009
    Terminated
    September 24, 2010
    Address
    595 Miner Road, Cleveland, OH, 44143-2131

    Description

    Respiratory Gating System, Catalog #NPTA540, Model #4535 674 26701, which includes: Pulmonary digital assembly kit and Pulmonary toolkit oncology Pro available on the following GEMINI PET/CT systems: GEMINI GXL 16 slice configuration, Model Number: 4535 679 75691.

    Reason

    A leak between the Tube Interface and the Outlet Tube of the transducer for the Respiratory Gating System component may result in a failure of the device to produce respiratory correlated images.

    Action

    Philips Medical Systems Nuclear Medicine division initiated this recall by sending a 'Customer Advisory Notification to their customer accounts on 11/24/2008. This notification informs the customer of the potential for the device equipped with the Pulmonary Gating Option to develop an air leak which could result in the device being unable to produce the desired respiratory correlated images. The notification provides field test instructions and recommends that the customer test the bellows on each day of use in order to assess that the unit is functioning properly. If the bellows device fails the test the recalling firm recommends that the unit not be used and that the recalling firm be contacted via telephone or E-mail. The firm intends to conduct a field correction of the affected units in which their Field Service Engineers will install upgrade kits on the affected devices tentatively scheduled to begin in September, 2009.

    Distribution

    Worldwide distribution: USA, Puerto Rico, Canada, Belgium, China, Denmark, Egypt, France, Germany, Hong Kong, India, Japan, Netherlands, Pakistan, Philippines, Poland, Saudi Arabia, Singapore, South Korea, Spain, and Sweden.

    Quantity

    20 units