BEUDAMED
    FDA Recall Open, Classified

    Allon 2001. Part Number: 200-00263

    Recall: Z-1966-2025 · Initiated May 13, 2025

    Recall

    Recall Number
    Z-1966-2025
    Event Number
    96854
    Firm
    Belmont Instrument LLC
    FEI Number
    1219702
    Product Code
    DWJ
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    May 13, 2025
    Posted
    June 12, 2025
    Address
    780 Boston Rd, Billerica, MA, 01821-5925

    Description

    Allon 2001. Part Number: 200-00263

    Reason

    An investigation into a report of the patient wrap (ThermoWrap), used with the Allon device, exceeding the set temperature determined that if: 1. The Human Sensor Board is disconnected from the Controller Board in the Allon device AND the temperature alarms are disabled, or 2. The Water In and Water Out and Thermostat sensors are disconnected from the Human Sensor Board AND the temperature alarms are disabled, the device will proceed to heat the water above the hardware fault limit without notifying the user of the faulty condition.

    Action

    Belmont Medical Technologies notified consignees via letter on about 05/13/2025. Consignees were instructed to ensure users of the devices are made aware of the correction, identify affected units on hand and check their serial numbers, ensure all devices have the Temp Sensor Alarms always set to ON to ensure that the user is alerted to errors and conditions requiring actions and attach the provided Step by Step Guide (P/N DDT-063-027) to each device. Consignees were also instructed to complete and return the response form and notify customers if the units were further distributed.

    Distribution

    Worldwide - US Nationwide distribution in the states of CA, DC, LA, MA, NM, PA, TX, VA, WA and the countries of Belgium, Bolivia (Plurinational State of), Brazil, Canada, Colombia, Israel, Italy, Portugal, Romania, Sweden, Taiwan (Province of China), Thailand, United Kingdom.

    Quantity

    229 units