Recall Z-1785-2010 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Mindray DS USA, Inc., dba Datascope Patient Monitoring
Passport V Monitor: Mindray, North America. Mindray DS USA, Inc. Mahwah, NJ 07430. Intended for intra hospital use under the direct supervision of a healthcare practitioner for the monitoring of various human physiological parameters.
| Date | Jun 10, 2010 (initiated Apr 28, 2010) |
| Status | Terminated |
| Reason | An issue with the Passport V Monitor has been identified where the Arrhythmia Analysis, ST Analysis and Invasive Blood Pressure functions are not operational. |
| Root cause | Software design |
| Action | Mindray issued Corrective action letters directly to all customers beginning April 28, 2010 by certified mail, return receipt requested. consignees were informed of the affected product. For further information, contact Mindray DS USA, Inc. at 1-201-995-8391. |
| Quantity | 24 US, 17 International |
| Distribution | Worldwide Distribution -- United States (OH, TX, AZ, NY, MO, IL, FL and TN), Spain, Indonesia, Brazil, Italy, Columbia and British West Indies. |
| 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 |