BEUDAMED
    FDA Enforcement Class II Terminated

    Large Stealth Chamber, Catalog Numbers: DS50-001-XL-T, DS50-002-XL-T, DS50-003-XL-T, DS50-102-XL-T, DS50-103-XL-T

    Recall: Z-2220-2017 · Reported June 14, 2017

    Enforcement

    Recall Number
    Z-2220-2017
    Event ID
    77301
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Iba Dosimetry
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 14, 2017
    Initiation Date
    April 26, 2017
    Classification Date
    June 2, 2017
    Termination Date
    June 11, 2018
    Address
    3150 Stage Port Drive, Suite 110, Bartlett, TN, 38133, United States

    Description

    Large Stealth Chamber, Catalog Numbers: DS50-001-XL-T, DS50-002-XL-T, DS50-003-XL-T, DS50-102-XL-T, DS50-103-XL-T

    Reason

    When the Stealth Chamber is used as a reference detector in relative dosimetry, deviation in the measured PDDs at shallow depths and geometric shadowing of measured profiles may appear.

    Code Info

    DS50-001-XL-T, Serial Numbers: 24887, 25084, 25085 DS50-002-XL-T, Serial Numbers: 24185, 25219, 25470, 24073, 24187, 24480, 24888, 25089, 24889, 24184, 24813, 24814, 24866, 24867, 24890, 25088, 25220, 24482, 24186, 25090, 24626, 24074, 24189, 25218, 25468, 25469 DS50-003-XL-T, Serial Numbers: 24437, 24260, 24639, 25472, 24257, 24291, 24630, 24640, 24868, 25093, 25478, 24180, 24182, 24259, 24323, 24439, 25222, 24179, 24290, 24293, 24633, 24637, 25091, 25223, 24627, 24077, 24634, 24438, 25476, 25221, 24292, 24263, 24322, 24435, 24628, 24642, 25094, 25479, 24177, 24178, 24641, 25481, 24261, 24076, 24871, 25224, 24078, 24079, 24080, 24175, 24176, 24183, 24256, 24258, 24262, 24264, 24265, 24289, 24321, 24436, 24629, 24631, 24635, 24636, 24638, 24869, 24891, 24892, 24893, 24894, 24896, 24897, 25092, 25095, 25225, 25477 DS50-102-XL-T, Serial Numbers: 24190, 24481, 25467 DS50-103-XL-T, Serial Numbers: 24870, 24898

    Distribution

    Worldwide Distribution - USA (nationwide) and to the countries of : Argentina, Australia, Austria, Canada, Cyprus, France, Germany, Hong Kong, Ireland, Islamic Republic of, Israel, Italy, Japan, Kingdom of Saudi Arabia, Kuwait, New Zealand, People's Republic of China, Philippines, Russia, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, R.O.C., and United Kingdom.

    Quantity

    110 units