BEUDAMED
    FDA Recall Terminated

    Capintec CRC 25 PET, item number 5130-3217 with Software Revisions 2.01 and 2.02 PET dose calibrator

    Recall: Z-0177-2012 · Initiated July 8, 2011

    Recall

    Recall Number
    Z-0177-2012
    Event Number
    59425
    Firm
    Capintec Inc
    FEI Number
    2518443
    Product Code
    KPT
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 8, 2011
    Posted
    November 9, 2011
    Terminated
    December 10, 2013
    Address
    620 Alpha Dr, Pittsburgh, PA, 15238

    Description

    Capintec CRC 25 PET, item number 5130-3217 with Software Revisions 2.01 and 2.02 PET dose calibrator

    Reason

    Software error in Rev. 2.01 and Rev 2.02 for Capintec CRC 25PET

    Action

    Capintec, Inc. sent a Software Error Alert letter dated July 8, 2011, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contac their Capintec Customer Support Representative to receive a software upgrade. For questions call Capintec Customer Support at 1-800-631-3826.

    Distribution

    Worldwide distribution - United States including CA, FL, IL, MA, NJ, OK, PA, and VA; and internationally to Brazil, China, India, Indonesia, Italy, Japan, Korea, South Korea, and Turkey.

    Quantity

    69