Recall Z-0153-2023 ยท DWJ System, Thermal Regulating
Belmont Instrument Corporation
CritiCool, thermoregulation device
| Date | Oct 31, 2022 (initiated Jul 20, 2021) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Component design/selection |
| Action | On September 28, 2022, the firm issued Urgent Medical Device Recall letters to affected customers. If the device is operating properly, customers may continue to use the device as intended with increased oversight during use while awaiting inspection and repair. The customer was provided with actions to take if a HALT 4 message is displayed on the device. While customers wait for their devices to be inspected and repaired, Belmont Medical Technologies recommends that you evaluate your clinical needs and consider planning for alternative methods of thermoregulation in case of failure. Belmont |
| Quantity | 158 (US); 803 (OUS) |
| Distribution | Domestic distribution nationwide. Foreign distribution worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083662 | CRITICOOL Mtre Advanced Technology , Ltd., Mar 26, 2009 |