BEUDAMED
    FDA Recall Terminated

    ViSi Mobile Monitor, Catalog No. 92-10010 The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients.

    Recall: Z-1817-2013 · Initiated May 23, 2013

    Recall

    Recall Number
    Z-1817-2013
    Event Number
    65718
    Firm
    Sotera Wireless, Inc.
    FEI Number
    3009673645
    Product Code
    MWI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 23, 2013
    Posted
    July 29, 2013
    Terminated
    September 9, 2013
    Address
    9444 Waples St, # 280, San Diego, CA, 92121-2939

    Description

    ViSi Mobile Monitor, Catalog No. 92-10010 The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients.

    Reason

    Sotera Wireless, Inc. is recalling the ViSi Mobile Monitoring System due to the potential for the Chest Sensor to cause a blister wound.

    Action

    Sotera sent an Urgent Product Recall letter dated May 23. 2013, to all affected customers. The letter informed the customers of the problems identified and the actions to be taken. Customers were instructed to report any adverse reactions experienced with the use of this product and or quality problems to the FDA's MedWatch Program by: www.fda.gov/medwatch, (800) FDA-1008, fax (800) FDA-0178. Customers were also instructed to contact Sotera Wireless Technical Support at (866) 794-5526 for questions.

    Distribution

    US distribution including CA and UT.

    Quantity

    90 units