Recall Z-1966-2025 ยท DWJ System, Thermal Regulating
Belmont Instrument LLC
Allon 2001. Part Number: 200-00263
| Date | Jun 12, 2025 (initiated May 13, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K024128 | ALLON 2001 VERSION 5 Mtre Advanced Technology , Ltd., Feb 10, 2003 |