Recall Z-2549-2016 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Mindray DS USA, Inc. dba Mindray North America
Mindray DS USA Inc., Passport Series Patient Monitor intended for monitoring, displaying, reviewing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12-lead selectable, arrythmia detection, ST segment analysis, and heart rate (HR), Respiration rate.
| Date | Jun 23, 2016 |
| Status | Terminated |
| Reason | Mindray has identified a potential leakage issue with the CO2 Module's Dryline II Water Trap used with the Passport Series Patient Monitor. |
| Root cause | Under Investigation by firm |
| Action | Mindray DS USA inc sent a recall letter on 6/23/2016 to their customers. |
| Quantity | 360 units |
| Distribution | Nationwide, Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143195 | Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1) Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd., Dec 22, 2014 |