Recall Z-0630-2013 ยท MSX System, Network And Communication, Physiological Monitors
Mindray DS USA, Inc. d.b.a. Mindray North America
DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and or WLAN connections. The DPM Central Station is used for remote monitor manag
| Date | Jan 3, 2013 (initiated May 12, 2011) |
| Status | Terminated |
| Reason | There is a software anomaly with the DPM Central Monitoring System where the trend data of one patient maybe replaced with the trend data of a second patient. |
| Root cause | Software design |
| Action | Mindray sent a Product Corrective Action letter dated May 12, 2012, to all affected customers via certified mail return receipt requested to two medical facilities. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that the issue would be corrected through a softweare upgrade of the affected product. A Mindray Service Representative would contact their facility to arrange for the software upgrade at no cost to them. For questions regarding this recall call 1-800-288-2121. |
| Quantity | two units |
| Distribution | Nationwide Distribution including OH and GA |
| 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 |