BEUDAMED
    FDA Enforcement Class II Terminated

    CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marking control software. Laser systems for patient alignment.

    Recall: Z-1709-2014 · Reported June 11, 2014

    Enforcement

    Recall Number
    Z-1709-2014
    Event ID
    68266
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    LAP of America Laser Applications, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 11, 2014
    Initiation Date
    October 7, 2013
    Classification Date
    June 3, 2014
    Termination Date
    September 14, 2016
    Address
    161 Commerce Rd Ste 3, Boynton Beach, FL, 33426-9385, United States

    Description

    CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marking control software. Laser systems for patient alignment.

    Reason

    Potential for patient to be marked incorrectly. Customers currently using CARINAsim or CARINAiso systems can encounter two safety relevant errors in the operating instructions (CARINAsim MAN-1236 Rev 2 / CARINAiso MAN-1237 Rev 2)

    Code Info

    CARINAiso = Part # 0007536-0001 CARINAsim = Part #0007535-0002

    Distribution

    Worldwide Distribution -- USA, including the states of AK, AZ, CA, CT, DC, FL, GA, IA, ID, IL, KS, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WY and the territory of Puerto Rico; and, the countries of Brazil, Canada, Chile, Colombia, Cuba, Honduras, and Mexico.

    Quantity

    280 Manuals