FDA Device recall Z-0933-2014
The Gaymar Medi-Therm device provides a means of regulating patient temperature by supplying temperature-controlled water through a connect…
- FDA Device
- Class II
- terminated
- Published 2014-02-12
On 2014-02-12 the FDA classified a Class II recall of The Gaymar Medi-Therm device provides a means of regulating patient temperature by supplying temperature-controlled water through a connect… by Stryker Medical Division, citing 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 patie….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0933-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-12-27 |
| Published | 2014-02-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stryker Medical Division |
| Distribution | US |
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
Identifiers
| code_info | Domestic Serial Numbers MTA7900C01023 MTA7900E01043 MTA7900F01021 MTA7900F90020…Domestic Serial Numbers MTA7900C01023 MTA7900E01043 MTA7900F01021 MTA7900F90020 MTA7900G90007 MTA7900B90022 MTA7900B90023 MTA7900D80022 MTA7900B01006 MTA7900B01009 MTA7900B01012 MTA7900H90007 MTA7900H90008 MTA7900A01019 MTA7900A01020 MTA7900A01024 MTA7900D01028 MTA7900F01002 MTA7900H80009 MTA7900H80021 MTA7900G90016 MTA7900H90006 MTA7900K90056 MTA7900K90061 MTA7900K90063 MTA7900L90003 MTA7900L90006 MTA7900L90020 MTA7900H80057 MTA7900E01016 MTA7900I90006 MTA7900I90038 MTA7900B90020 MTA7900E80014 MTA7900E80020 MTA7900E80027 MTA7900I90023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0933-2014%22
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