Recall Z-1280-2015 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Mindray DS USA, Inc. dba Mindray North America
Passport V Monitor, Multiparameter Patient Monitor(with Arrhythmia Detection and Alarms) Intended for intra hospital use under the direct supervision of a licensed healthcare practitioner.
| Date | Mar 16, 2015 (initiated Jan 23, 2015) |
| Status | Terminated |
| Reason | An issue has been identified with Passport V Monitors invasive blood pressure function (IBP) which may provide an incorrect IBP measurement |
| Root cause | Process control |
| Action | Mindray DS USA Inc sent Urgent: Passport V Monitor Field Corrective Action letters dated 1/23/2015 to hospital administrators. The letters informed customers that the IBP module may provide an incorrect IBP measurement. The letter also explained the adverse effects on patients. Customers are asked to either calibrate the IBP following the instructions provided; or, contact a Mindray Service Representative, who can perform the calibration, at 1-800-288-2121. In the case of the second option, it is recommended that the monitor be removed from service until the calibration is performed. If t |
| Quantity | 519 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091834 | PASSPORT V MONITOR, MODEL 0998-00-6100 Datascope Corp., Patient Monitoring Division, Jul 15, 2009 |