BEUDAMED
    FDA Enforcement Class II Terminated

    CSA Medical truFreeze System; Model: CC3-01, a cryogenic surgical device ***The involved units are those with the newest version of a panel PC referred to as POC-127. These panels are identified by serial number. *** The truFreeze is intended for cryogenic destruction of tissue requiring either active or passive venting during surgical procedures. The truFreeze is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign and malignant lesions.

    Recall: Z-0941-2015 · Reported January 14, 2015

    Enforcement

    Recall Number
    Z-0941-2015
    Event ID
    69806
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CSA Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 14, 2015
    Initiation Date
    November 10, 2014
    Classification Date
    January 7, 2015
    Termination Date
    March 25, 2015
    Address
    91 Hartwell Ave, N/A, Lexington, MA, 02421-3137, United States

    Description

    CSA Medical truFreeze System; Model: CC3-01, a cryogenic surgical device ***The involved units are those with the newest version of a panel PC referred to as POC-127. These panels are identified by serial number. *** The truFreeze is intended for cryogenic destruction of tissue requiring either active or passive venting during surgical procedures. The truFreeze is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign and malignant lesions.

    Reason

    An increase in complaint trending for a loss of audible sound associated with the timer has been observed.

    Code Info

    Console SN/Lot NO: 01-00109, 01-00112, 01-00113, 01-00115, 01-00120, 01-00121, 01-00122, 01-00123, 01-00132, 01-00133, 01-00135, 01-00137, 01-00142, 01-00148, 01-00156, 01-00159, 01-00160, 01-00161, 01-00162, 01-00163, 01-00165, 01-00166, 01-00168, 01-00169, 01-00170, 01-00171, 01-00172, 01-00173, 01-00174, 01-00175, 01-00176, 01-00177, 01-00178, 01-00179, 01-00180, 01-00181, 01-00182, 01-00183, 01-00185, 01-00186, 01-00187, 01-00188, 01-00189, 01-00190, 01-00191, 01-00192

    Distribution

    US Distribution to states of: AR, CA, CO, CT, DC, FL, GA, IL, IN, LA, MA, MD, MI, NC, NJ, NY, OK, PA, RI, SC, TN, TX, UT, VA, and WV.

    Quantity

    46