BEUDAMED
    FDA Enforcement Class II Terminated

    Welch Allyn ProBP 2400 Digital Blood Pressure Device #2400, REF 901096, Rx ONLY, Made in China --- Distributed by Welch Allyn Inc., 4341 State Street Road, Skaneateles Falls, NY 13153 --- Microlife Corporation 9F, 431, RuiGuang Road, NeiHu, Taipei, 11492, Taiwan, R.O.C. --- Microlife AG Espenstrasse 139 9443 Widnau, Switzerland

    Recall: Z-1777-2017 · Reported April 19, 2017

    Enforcement

    Recall Number
    Z-1777-2017
    Event ID
    76552
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Welch Allyn Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 19, 2017
    Initiation Date
    February 27, 2017
    Classification Date
    April 11, 2017
    Termination Date
    June 14, 2019
    Address
    4341 State Street Rd, N/A, Skaneateles Falls, NY, 13153-5300, United States

    Description

    Welch Allyn ProBP 2400 Digital Blood Pressure Device #2400, REF 901096, Rx ONLY, Made in China --- Distributed by Welch Allyn Inc., 4341 State Street Road, Skaneateles Falls, NY 13153 --- Microlife Corporation 9F, 431, RuiGuang Road, NeiHu, Taipei, 11492, Taiwan, R.O.C. --- Microlife AG Espenstrasse 139 9443 Widnau, Switzerland

    Reason

    A defective electrical component in the battery charging circuit in two lots of the ProBP 2400 may potentially cause an over-voltage battery charging condition when the device is connected to the external power supply/battery charger. This potential defect resides with the device, not the battery. The over-voltage condition can result in high NiMH battery temperatures that, in some cases, can reach levels sufficient to cause melting of the plastic battery door and other adjacent plastic and foam device components.

    Code Info

    Lot Number 0715: Serial Number range (21)07150001 -  (21)07150620; Lot Number 1215: Serial Number range (21)12150001 -  (21)12150500; --- Note: (21) is NOT part of the serial number. It is the Global Unique Device Identification (GUDI) Application Identifier that precedes the serial number on any GUDI compliant label.

    Distribution

    Worldwide Distribution - USA (nationwide) Distribution

    Quantity

    981 units