CritiCool, thermoregulation device

FDA device recall Z-0153-2023 · posted 2022-10-31 · Open, Classified

Recall details

Recalling firm

Belmont Instrument Corporation

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.

Action taken

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 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. For any questions regarding this action, technical assistance or to report an adverse event or product complaint, please contact Belmont Medical Technologies using the following information: 1-855-387-4547 TECHSUPPORT@BELMONTMEDTECH.COM

Root cause

Component design/selection

Status

Open, Classified

Product code

DWJ

Quantity affected

158 (US); 803 (OUS)

Distribution

Domestic distribution nationwide. Foreign distribution worldwide.

Date initiated

2021-07-20

Date posted

2022-10-31

Location

Billerica, MA

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