BEUDAMED
    FDA Recall Terminated

    CIVCO Arm Support, REF 106047, distributed as: (a) Rigid Arm Support, Large, Set, Red (PN: 106047) (b) PB2-BDLRL (PN: 109040) (c) Rigid Adj. Arm Support, Large, Set (PN: 106048) (d) PSR2-CF-DLRL-2P Posirest-2 (PN: 106522) The Rigid Arm Supports are utilized on the Posibboard2 and Posirest assemblies, which are intended to position the patients upper extremities during breast and lung diagnostic and radiotherapy treatment.

    Recall: Z-3083-2017 · Initiated August 10, 2017

    Recall

    Recall Number
    Z-3083-2017
    Event Number
    77874
    Firm
    Med Tec Inc
    FEI Number
    1000143606
    Product Code
    KXH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 10, 2017
    Terminated
    March 19, 2024
    Address
    1401 8th St SE PO Box 320, Orange City, IA, 51041-7463

    Description

    CIVCO Arm Support, REF 106047, distributed as: (a) Rigid Arm Support, Large, Set, Red (PN: 106047) (b) PB2-BDLRL (PN: 109040) (c) Rigid Adj. Arm Support, Large, Set (PN: 106048) (d) PSR2-CF-DLRL-2P Posirest-2 (PN: 106522) The Rigid Arm Supports are utilized on the Posibboard2 and Posirest assemblies, which are intended to position the patients upper extremities during breast and lung diagnostic and radiotherapy treatment.

    Reason

    Rigid Arm Supports (PN: 106015 and 106047), which were used as part of the Posiboard-2 and Posirest, and were distributed as PN: 106015, 106047, 106521, 106522, 109030, and 109040 between Ocotober 2009 and July 2012 may have a height difference of approximately 17mm.

    Action

    CIVCO sent an Urgent: Field Action Notice- Customer Communication letter dated July 20th, 2017. The field action notification letter was sent on August 10, 2017, by email requesting the consignee review their inventory and contact their sales representative for product replacement. Enclosed please find a notification letter which is required to be sent to all customers who received this product. Please contact your Insides Sales Representative concerning replacement instructions if you have any questions. You may reach your representative by calling CIVCO Radiotherapy, at 712-737-8688 between 8:00AM and 5:00PM CST. For further question, please call (319) 248-6537.

    Distribution

    Worldwide Distribution - US Distribution to the states of : MI, IL and TX., and to the countries of : Greece, Australia, Czech Republic, Hungary, Norway, Brazil, Italy, Switzerland ,UK, Austria, Slovenia, Croatia, Poland, Germany, Japan, France, Netherland, Sri Lanka, Pakistan, Bangladesh, and Israel

    Quantity

    30 units