The Gaymar Medi-Therm device provides a means of regulating patient temperature by supplying temperature-controlled water through a connector hose to accessory Gaymar Hyper/Hypothermia blanket(s)/body wrap(s). The blanket/body wrap provides an interface for heating or cooling the patient. Accessory YSI 400 series patient probe interfaces between the Medi-Therm and patient to sense patient temperature, which is displayed on the device's control panel. The Medi-Therm device controls output water temperature by mixing hot and cold water using hot and cold solenoid valves under microprocessor control. The device includes a circulating pump, heater and refrigeration system. The Medi-Therm controller, connector hose, blanket/body wrap and patient probe comprise the Medi-Therm Hyper/Hypothermia System.

Stryker Medical has identified that on some units of the MTA7900, there is a lack of a water temperature display while the unit is in Auto mode. While in Auto mode, only the patient temperature is displayed along with the set point. The water display will be blank during Auto mode. If the user wants to see the water temperature displayed and switches out of Auto mode to Manual mode, then back to

On Dec. 27, 2013, Stryker Medical notified their consignees, identifying the product, reason for the recall and associated risks. Consignees were asked . Locate the units listed attach enclosed warning tags to the units listed. For units that do not have the water temperature displayed, advise staff not to switch to manual mode in order to display the water temperature. Stryker will make arrangements to update the software so that the water temperature will be displayed in both Auto and Manual modes. Fax (269-488-8691) or e-mail ([email protected] ) the enclosed acknowledgment to confirm receipt of this notification. Please forward a copy of this letter to the new users and advise us of their new location and let Stryker know if any units have been discontinued. Questions or concerns, should be addressed to Stryker Customer Service at (1-800-327-0770). Monday-Friday 8 a.m-5 p.m. (ET).