Recall Z-1966-2025— Belmont Instrument LLC
Class II · Ongoing
Class II FDA medical device recall by Belmont Instrument LLC, initiated 2025-05-13. It names one FDA 510(k) clearance: K024128. Product: 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..
- Recalling firm
- Belmont Instrument LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-05-13
- Firm location
- Billerica, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.