Recall Z-0939-2013 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Draeger Medical, Inc.
Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo) Physiological patient monitoring system.
| Date | Mar 11, 2013 (initiated Dec 13, 2012) |
| Status | Terminated |
| Reason | The displayed value for the invasive blood pressure measurement of the IACS was different than the actual patient values. Liquid ingress in the cable connection may cause inaccurate measurements. This can happen if the Dual Hemo MCable is used in a non-vertical position, a vertical position but upside down, or laying it on the floor or on the patient bed. |
| Root cause | Labeling design |
| Action | Drager sent an "URGENT MEDICAL DEVICE RECALL" letter dated December 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 1-800-543-5047 for questions relating to this notice. |
| Quantity | 260 |
| Distribution | Distributed in the states of CA, IL, and MA. |
| FDA record | Open on fda.gov |