| | Class 2 Recall
DPM Central Station |  |
| Date Posted |
January 03, 2013 |
| Recall Number |
Z-0630-2013 |
| Product |
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 management, storing, printing, reviewing, or processing of information from net worked devices, and it is operated by medical personnel in hospitals or medical institutions. |
| Code Information |
510 K K080192
P/N 300BF-PA200002
|
Recalling Firm/
Manufacturer |
Mindray DS USA, Inc. d.b.a. Mindray North America
800 MacArthur Blvd.
Mahwah, New Jersey 07430 |
| Consumer Instructions |
For questions or assistance in notifying accounts about this recall, contact Philips at 1-800-722-9377. |
| For Additional Information Contact |
Ms. Diane Arpino
201-995-8407
|
Reason for
Recall |
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.
|
| 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 in Commerce |
two units |
| Distribution |
Nationwide Distribution including OH and GA |
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