BEUDAMED
    FDA Recall Terminated

    AquaStar Water Caloric Irrigator; water caloric stimulator; Manufactured for/Distributed by Micromedical Technologies, Inc., 10 Kemp Drive, Chatham, IL 62629 USA, Instrumentation Difra, Made in Belgium. The AquaStar water caloric irrigator delivers a precisely controlled temperature and flow rate of cool or warm water for vestibular stimulation during caloric testing. The caloric tests evaluate the viability of the horizontal semicircular canal by stimulating them with warm and cool water while the patient's eyes are closed. The resulting dizziness and nystagmus is taken as an index of the viability of the organ. The eyes are then opened to evaluate the ability of the CNS to visually suppress inappropriate dizziness and nystagmus.

    Recall: Z-0563-2010 · Initiated November 16, 2009

    Recall

    Recall Number
    Z-0563-2010
    Event Number
    53837
    Firm
    Micromedical Technologies, Inc
    FEI Number
    1450721
    Product Code
    ETP
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 16, 2009
    Posted
    December 23, 2009
    Terminated
    April 18, 2011
    Address
    10 Kemp Dr, Chatham, IL, 62629

    Description

    AquaStar Water Caloric Irrigator; water caloric stimulator; Manufactured for/Distributed by Micromedical Technologies, Inc., 10 Kemp Drive, Chatham, IL 62629 USA, Instrumentation Difra, Made in Belgium. The AquaStar water caloric irrigator delivers a precisely controlled temperature and flow rate of cool or warm water for vestibular stimulation during caloric testing. The caloric tests evaluate the viability of the horizontal semicircular canal by stimulating them with warm and cool water while the patient's eyes are closed. The resulting dizziness and nystagmus is taken as an index of the viability of the organ. The eyes are then opened to evaluate the ability of the CNS to visually suppress inappropriate dizziness and nystagmus.

    Reason

    Some of the filters on both the display board and the main electronic board (PCB) become oxidized causing the LCD display to be garbled and the timer will not operate.

    Action

    Micromedical Technologies, Inc. sent letters dated November 16, 2009 via e-mail (with read receipt) to each customer and their representative. If they did not have the customer's e-mail address, the sales representative was requested to forward the letter to the customer and copy Micromedical. The letters advised the customers that one or more electronic components in the AquaStar caloric irrigator may fail due to contact corrosion. In the event of this failure, unheated tap water will continue to flow through the device back to the water drain, but the LCD display will be garbled and the timer will not operate. If this problem develops, the account should stop using the irrigator and contact Micromedical Technologies, Inc. at 1-217-483-2122 or via e-mail at [email protected] to report the problem for repair of the unit.

    Distribution

    Worldwide Distribution -- United States (New York and Pennsylvania), Canada, Egypt, Korea, Poland and South Africa.

    Quantity

    10 units