The Gaymar Medi-Therm device provides a means of regulating patient… — Class II medical device recall Z-0933-2014
Terminated recall by Stryker Medical Division of Stryker Corporation, reported 2014-02-12, distributed nationwide. Stryker Medical has identified that on some units of the MTA7900, there is a lack of a water temperature displ
| Recall number | Z-0933-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Medical Division of Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2013-12-27 |
| Classified | 2014-02-05 |
| Reported by FDA | 2014-02-12 |
| Terminated | 2014-11-04 |
| Distributed | Nationwide (US) |
| Quantity | 1,002 units |
| Serial numbers | MTA7900A01001, MTA7900A01002, MTA7900A01003, MTA7900A01005, MTA7900A01006, MTA7900A01007, MTA7900A01008, MTA7900A01009, MTA7900A01010, MTA7900A01011, MTA7900A01012, MTA7900A01013, MTA7900A01014, MTA7900A01015, MTA7900A01016, MTA7900A01017, MTA7900A01018, MTA7900A01019, MTA7900A01020, MTA7900A01022, MTA7900A01024, MTA7900A01025, MTA7900A01026, MTA7900A01027, MTA7900A01028 and 475 more |
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 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
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.