PlainRecalls
FDA Devices Moderate Class II Ongoing

Allon 2001. Part Number: 200-00263

Reported: June 18, 2025 Initiated: May 13, 2025 #Z-1966-2025

Product Description

Allon 2001. Part Number: 200-00263

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.

Details

Recalling Firm
Belmont Instrument LLC
Units Affected
229 units
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.
Location
Billerica, MA

Frequently Asked Questions

What product was recalled?
Allon 2001. Part Number: 200-00263. Recalled by Belmont Instrument LLC. Units affected: 229 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 18, 2025. Severity: Moderate. Recall number: Z-1966-2025.