device · product 1 of 1
Allon 2001. Part Number: 200-00263
- Recall number
- Z-1966-2025
- Initiated
- May 13, 2025
- Classification
- Class II
- Status
- Ongoing
- Recalling firm
- Belmont Instrument LLC
- Quantity
- 229 units
App-derived interpretation
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.
Official device-enrichment evidence · Sourced
Device Design
Inspect official wording and provenance
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.
Code information
Part Number: 200-00263. UDI-DI: 007290107581103, Serial Numbers: 99111143000002, 99111143000014, 99111627300034, 9993901600001, 9993901600002, 9993901600004, 9993901600006, 9993901600007, 9993901600009, 9995356300005, 9995356300006, 9995356300007, 9995356300008, 9996673800002, 99111143000001, 99111143000003, 99111143000004, 99111143000007, 99111143000008, 99111143000009, 99111143000011, 99111143000012, 99111143000013, 99111143000015, 99111143000018, 99111143000019, 99111288700016, 99111288700021, 99111288700035, 99111288700036, 99111627300011, 99111627300017, 99111627300022, 99111627300029, 99111627300040, 99111627300041, 99111627300045, 99111627300046, 99111627300054, 99111627300057, 99111627300064, 99111627300067, 99113168300004, 99113168300005, 99113168300008, 99113168300010, 99113168300012, 99128623400008, 99129614700002, 99129614700005, 99131046400001, 99131046400003, 99131046400004, 99131046400005, 99131046400006, 99131046400009, 99131046400011, 99131046500007, 99132732400009, 99132732400018, 99132732400019, 99134232100011, 99132121000010, 99113168300003, 9983349800008, 9991451200002, 9991451200004, 9992175000001, 9995356300010, 99111627300001, 99111627300008, 99113168300013, 99132121000014, 99132732400005, 99134232100001, 99134232100002, 99134232100003, 99134232100009, 99134232100022, 99134232100035, 99111627300042, 99111627300056, 99111627300058, 99111627300059, 99113168300014, 99111627300020, 99111627300049, 99113168300006, 99128623400003, 99132121000013, 99134232100018, 9991451200001, 99111143000006, 99111627300005, 99111627300035, 99113168300001, 99113168300002, 99113168300007, 99111627300053, 99111288700014, 99111288700017, 99111288700018, 99111288700019, 99111288700020, 99111627300016, 99111627300032, 99111143000017, 99111143000021, 99111143000022, 99111288700001, 99111288700002, 99129614700009, 9962076700011, 99132121000012, 99132121000015, 99132121000005, 99132121000007, 99111627300009, 99134232100017, 99131046400008, 9995356100003, 99113168300011, 99111627300025, 99132121000009, 99111627300061, 99111627300038, 9974083900001, 99111627300030, 9991451200006, 99111627300018, 9976534100006, 9945767700003, 9983349700008, 9991451200003, 9991451200009, 99111288700005, 99111627300031, 99128623400004, 99128623400005, 99128623400007, 99129614700001, 99129614700003, 99129614700004, 99129614700007, 99129614700008, 99131046400002, 99131046500001, 99131046500002, 99132121000001, 99128623400006, 99111143000016, 9969414000006, 99134232100013, 99134232100021, 99111627300036, 99132121000017, 99132121000018, 99132121000019, 99132121000020, 99132732400002, 99132732400006, 99132732400013, 99132732400014, 99134232100005, 99134232100010, 99132121000016, 99111627300013, 99111627300033, 99111627300043, 99111627300044, 99111627300051, 99111627300063, 99129614700006, 99111627300007, 99111627300024, 99111627300037, 99111627300047, 99111627300014, 99111627300052, 99113168300009, 99128623400001, 99128623400002, 99128623400009, 99128623400010, 99134232100008, 99111143000020, 99131046400010, 99132121000011, 99132732400007, 99132732400011, 99132732400012, 99132732400016, 99134232100034, 99132732400008, 99132732400015, 99132732400017, 99132732400020, 99134232100014, 9959060500014, 99111627300026, 99134232100004, ", 99134232100006", 9991451200005, 9995356200008, 99111143000010, 99111288700004, 99131046500003, 99131046500005, 9973536800007, 99131046500004, 99131046500008, 99131046500009, 99132121000004, 99132121000006, 99132121000008, 99134232100026, 99132732400001, 99132732400003, 99132732400004, 99134232100007, 99134232100019, 9940577300005, 99111143000005, 99111627300048, 99111627300062, 99132121000002, 9979841500003, 99132121000003, 99131046500010
Distribution pattern
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.