{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "196238", "product_res_number": "Z-0153-2023", "event_date_initiated": "2021-07-20", "event_date_posted": "2022-10-31", "recall_status": "Open, Classified", "res_event_number": "90939", "product_code": "DWJ", "k_numbers": [ "K083662" ], "product_description": "CritiCool, thermoregulation device", "code_info": "UDI-DI: 07290107581110\nSerial 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"firm_fei_number": "1219702", "recalling_firm": "Belmont Instrument Corporation", "address_1": "780 Boston Rd", "city": "Billerica", "state": "MA", "postal_code": "01821-5925", "additional_info_contact": "Lida Reed\n978-663-0212", "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.", "root_cause_description": "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.\n\nWhile 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.\n\nBelmont Medical Technologies will dispatch service technicians to customer sites to inspect and repair affected CritiCool devices. Customers will be contacted by the service technician to schedule a convenient time for the inspection and repair of customer devices.\n\nFor any questions regarding this action, technical assistance or to report an adverse event or product\ncomplaint, please contact Belmont Medical Technologies using the following information:\n1-855-387-4547\nTECHSUPPORT@BELMONTMEDTECH.COM", "product_quantity": "158 (US); 803 (OUS)", "distribution_pattern": "Domestic distribution nationwide. 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