Recall Z-0933-2014 ยท DWJ System, Thermal Regulating
Stryker Medical Division of Stryker Corporation
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 temperat
| Date | Feb 5, 2014 (initiated Dec 27, 2013) |
| Status | Terminated |
| 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 |
| Root cause | Device Design |
| Action | 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 (ProductFieldAction@stryker.com ) the enclosed acknowledgment |
| Quantity | 1002 units |
| Distribution | nationwide and worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K912051 | MEDI-THERM (MTA-5900) & DETACHABLE HOSES Gaymar Industries, Inc., Jul 30, 1991 |