BEUDAMED
    FDA Enforcement Class II Terminated

    Given Imaging Bravo¿ pH capsule delivery device, 5-pack. In-Vitro Diagnostic for pH monitoring of gastric reflux Item Number: FGS-0312 The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age. The Bravo pH Capsule can be attached following either endoscopy or manometry. The RAPID pH software is intended to record, store, view, and analyze gastroesophageal pH data.

    Recall: Z-1619-2016 · Reported May 18, 2016

    Enforcement

    Recall Number
    Z-1619-2016
    Event ID
    73882
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Covidien LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 18, 2016
    Initiation Date
    April 15, 2016
    Classification Date
    May 6, 2016
    Termination Date
    July 13, 2017
    Address
    60 Middletown Ave, N/A, North Haven, CT, 06473-3908, United States

    Description

    Given Imaging Bravo¿ pH capsule delivery device, 5-pack. In-Vitro Diagnostic for pH monitoring of gastric reflux Item Number: FGS-0312 The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age. The Bravo pH Capsule can be attached following either endoscopy or manometry. The RAPID pH software is intended to record, store, view, and analyze gastroesophageal pH data.

    Reason

    Potential of an allergic reaction in a patient with nickel sensitivity.

    Code Info

    All lot numbers

    Distribution

    Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Belgium, Brazil, Canada, Cyprus, El Salvador, Greece, Hong Kong, Israel, Mexico, Panama, Singapore, South Korea, and Thailand.

    Quantity

    12,895 units