CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A

There is a potential for the heating-chamber to malfunction resulting in melting/burning of the heater chamber components.

On 10/19/23, CardioQuip issued a "Urgent: Medical Device Correction" notification to all affected consignees. This notification was an update to the firm's May 22, 2023 communication. CardioQuip ask consignees to take the following actions: 1. Prime the MCH-1000(i) and MCH-1000(m) prior to each use. 2.Never operate the device dry (see communication for further details). 3. Design Changes to be implemented (see communication for further details). A. Relocation of the water Level Sensor (see communication for further details). B. Software Update (see communication for further details). 4. Please fill out and submit the receipt of understanding of the contents of this letter to CardioQuip within 5 business days or receipt. 5. Any adverse events experienced relating to CardioQuip devices should be reported to CardioQuip or through the FDA s MedWatch Program: Phone: +1 (800) FDA-1088 Web: www.fda.gov/medwatch/report.htm