Belmont Instrument LLC: Medical Device Recall in 2025 - (Recall #: Z-1966-2025)

Allon 2001. Part Number: 200-00263

Class II

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.

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

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.

Voluntary: Firm initiated