Recall Z-2058-2017 ยท DWJ System, Thermal Regulating
Stryker Medical Division of Stryker Corporation
Medi-Therm Hyper/Hypothermia System, MTA7900
| Date | Mar 29, 2017 |
| Status | Terminated |
| Reason | The water may reheat too quickly if the unit is in "Automatic" mode, switched to "Manual" mode to view water temperature, and then switched back to "Automatic" mode. |
| Root cause | Software design |
| Action | Stryker sent an URGENT: MEDICAL DEVICE CORRECTION notification dated March 29, 2017, were sent to the affected customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Actions needed 1. Locate the units listed on the attached business reply form and identify the address where they can be serviced. 2. In the interim, until the service can be performed, there are additional actions that users can and should take to ensure that the product operates |
| Quantity | 119 |
| Distribution | USA (nationwide) Distribution and Internationally to Colombia. |
| 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 |