BEUDAMED
    FDA Recall Terminated

    GE Optional Laser Centering Device X-ray generator.

    Recall: Z-2320-2015 · Initiated November 10, 2014

    Recall

    Recall Number
    Z-2320-2015
    Event Number
    69849
    FEI Number
    2519904
    Product Code
    RER
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    November 10, 2014
    Posted
    August 13, 2015
    Terminated
    February 1, 2017
    Address
    Rd, GE Inspection Technologies, LP 50 Industrial Park, Lewistown, PA, 17044-9312

    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.

    Action

    GE's Planned Action for repair: 1. Replacement compliant laser centering devices will be shipped to purchasers, with prepaid shipping envelopes for purchasers to return the noncompliant units to GE. 2.All mailings will be made at no cost to the purchaser; and 3.The corrections will be completed by November 1, 2015 Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator are to be included in the notification. For further questions please call (717) 447-1278.

    Distribution

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

    Quantity

    25