BEUDAMED
    FDA Recall 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 · Initiated April 26, 2017

    Recall

    Recall Number
    Z-2220-2017
    Event Number
    77301
    Firm
    Iba Dosimetry
    FEI Number
    3001238439
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 26, 2017
    Terminated
    June 11, 2018
    Address
    3150 Stage Port Drive, Suite 110, Bartlett, TN, 38133

    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.

    Action

    IBA Dosimetry sent an Field Safety Notice dated April 21, 2017. The letter informed the consignee of the issue and provided the following instruction: If a Stealth Chamber was used during commissioning of Linear Accelerator and Treatment Planning System, the consignee was asked to consider referenced deviations for larger field sizes (>20 x 20 cm) and higher energies (>60MV). They were also instructed to recheck the influence of the PDD deviation and insufficient clearance for 40 x 40 profile on their beam model and its clinical relevancy. For further questions please call (901) 268-6430. Contact information Should you have questions or require additional information, please contact the Customer Service Team at:: South and Middle America, USA, and Canada : IBA Dosimetry America Bartlett, TN, USA US [email protected] .com Phone: +1 901 386-2242 Fax: +1 901 382-9453 Asia Pacific, A Australia and New Zealand: IBA China, Dosimetry Dept. Beijing, China Service [email protected] .com Phone: +86 10 8080 9107 Fax: + 86 10 80809298 All other countries: IBA Dosimetry GmbH, Service Dept. Schwarzenbruck , Germany [email protected] .com Phone: +49 9128 607-38 Fax: +49 9128 607-26

    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