Recall Z-2634-2017 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Mindray DS USA, Inc. dba Mindray North America
TI Transport Monitor/Module Battery Pack Product Usage: intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters.
| Date | Apr 28, 2017 |
| Status | Terminated |
| Reason | Mindray has received two reports from outside the United States that the battery pack for TI transport monitor/module overheated. |
| Root cause | Under Investigation by firm |
| Action | Mindray notified their customers on April 28, 2017.Customers are provided information regarding this correction. Once the customer has identified the batteries, the customer should contact Mindray Customer Service to arrange for the no charge delivery of replacements. Mindray Customer Service representatives may be reached at (800) 288-2121 (Option 3), Monday through Friday 8:30 amd -5:30 pm, ET. |
| Quantity | 2718 batteries |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152902 | Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Feb 18, 2016 |