Recall Z-0933-2014— Stryker Medical Division of Stryker Corporation

Name: FDA recall Z-0933-2014
Creator: U.S. Food and Drug Administration
Published: 2013-12-27

Class II · Terminated

Class II FDA medical device recall by Stryker Medical Division of Stryker Corporation, initiated 2013-12-27, terminated 2014-11-04. It names one FDA 510(k) clearance: K912051. Product: 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.. Reason: 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.

Recalling firm: Stryker Medical Division of Stryker Corporation
Classification: Class II
Status: Terminated
Initiated: 2013-12-27
Terminated: 2014-11-04
Firm location: Portage, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K912051 — MEDI-THERM (MTA-5900) & DETACHABLE HOSESGaymar Industries, Inc.·cleared 1991-07-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.