Medical Device Recall: Allon 2001. Part Number: 200-00263
Belmont Instrument LLC · May 13, 2025
Reason for Recall
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.
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.
States Affected
NATIONWIDE
Quantity Affected
229 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1966-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.