CritiCool, thermoregulation device
Check against the official notice below — it lists the full affected range.
Belmont Instrument Corporation is recalling its CritiCool thermoregulation device due to premature pump failure that can cause the device to display a HALT 4 error from which it cannot recover, even after rebooting. This malfunction may delay treatment and prevent the device from delivering prescribed thermoregulation therapy. The company has received one report of death potentially related to this issue. The recall affects 158 devices distributed in the United States and 803 devices distributed internationally.
The recall involves specific serial numbers of the CritiCool device identified by UDI-DI 07290107581110. The source document does not specify what remedy is available to affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Premature pump failure may lead to the device displaying a HALT 4 error, from which the device cannot recover even after device reboot. The issue may potentially lead to delayed treatment and a failure to deliver the prescribed thermoregulation therapy. To date, the firm has received one report of death potentially related to this issue.
Reason for recall: Premature pump failure may lead to the device displaying a HALT 4 error, from which the device cannot recover even after device reboot. The issue may potentially lead to delayed treatment and a failure to deliver the prescribed thermoregulation therapy. To date, the firm has received one report of death potentially related to this issue. Distribution: Domestic distribution nationwide. Foreign distribution worldwide. Quantity: 158 (US); 803 (OUS) Lot/code info: UDI-DI: 07290107581110 Serial Numbers: 9978580900011 99110698100043 99110698100044 9963715800012 9982077400003 9971040500004 9982294100006 9964294500006 9963715800008 9964294500007 9978580900008 9978580900009 9999186600019 99110008800035 99110008800036 99109321700020 99109321700026 99110992900020 99100663300011 99100663300014 99101637500005 99110698100048 9966227400007 9966227400012 9989990200008 9995915300007 9995915300014 9966227400008 9966227400011 9969231000003 9969231000004 9969231000005 9969570100004 9969570100014 9969570100018 99108208900030 99109321700010 9989990200012 99110992900011 9974072400005 99102316800013 9974085100011 9995355700003 99108208900023 99108208900025 996622740007 9969570100016 99104180900007 99107291500013 99107291500016 9983874900002 99108208900022 99109321700004 9978471200014 99100663300013 99100663300023 9995355500001 9995355500001 9995355500003 9995355500003 9996480200001 99104183000019 99104183000021 99110698100028 99110698100029 9982315400005 9982315400007 99110992900003 99110992900004 99110992900005 9964294500014 99102316800010 9999186600018 9999186600020 99100663300024 9974085100004 9989990200007 9995355500007 9974085100001 9974085100005 9974085100007 9974085100008 9974085100017 9974085100018 9974085100022 9974085100023 9974085100026 9975437700001 9969570200002 9969570100020 9976535500007 9976535500002 9986341600006 9986341600007 9986341600008 9975437700020 9981876000006 9981876000008 9982077400005 9982077400007 9982077400001 9995355600002 9
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.