Recall Z-0798-2013 ยท MSX System, Network And Communication, Physiological Monitors
Mindray DS USA, Inc. d.b.a. Mindray North America
Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002, and 300BF-PA00003 (DPM Central Monitoring System) 115-006908-01, -03, -04 (DPM software upgrade kit). The DPM Central Monitoring System transfers information between DPM Central station and other networked devices.
| Date | Feb 11, 2013 (initiated Nov 28, 2012) |
| Status | Terminated |
| Reason | Mindray has identified a software anomaly that may where, in the presence of an asystole, the Telepack ECG waveform may produce a unique step pattern (instead of a flat line) if Lead 1 or V is being utilized for detecting cardiac arrhythmia. |
| Root cause | Software design |
| Action | Mindray North America/ Mindray DS USA Inc. sent an "URGENT PRODUCT CORRECTION ACTION" letter dated November 28, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact your Mindray Service Representative at 1-800-288-2121 for questions relating to this issue. |
| Quantity | 51 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080192 | HYPERVISOR VI CENTRAL MONITORING SYSTEM (INCLUDING TMS) Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Apr 3, 2008 |