BEUDAMED
    FDA Enforcement Class II Terminated

    GE Optional Laser Centering Device X-ray generator.

    Recall: Z-2320-2015 · Reported August 19, 2015

    Enforcement

    Recall Number
    Z-2320-2015
    Event ID
    69849
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE Inspection Technologies, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 19, 2015
    Initiation Date
    November 10, 2014
    Classification Date
    August 13, 2015
    Termination Date
    February 1, 2017
    Address
    50 Industrial Park Rd, N/A, Lewistown, PA, 17044-9312, United States

    Description

    GE Optional Laser Centering Device X-ray generator.

    Reason

    GE has identified a potential failure to comply with 21 C.F.R. ¿ 1040.10 and 21 C.F.R. ¿ 1010.2 for the alignment laser centering device.

    Code Info

    Model No. 025.03.00A

    Distribution

    US Distribution to the states of : NY, CA, WA, PA, MD, AL, FL and LA.

    Quantity

    25