Recall Z-0630-2013
Mindray DS USA, Inc. d.b.a. Mindray North America · initiated May 12, 2011
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 510 K K080192 P/N 300BF-PA200002
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.
FDA-determined cause: Software design
Action taken
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.
Details
- Recall number
- Z-0630-2013
- Initiated
- May 12, 2011
- Posted by FDA
- January 3, 2013
- Terminated
- February 19, 2013
- Product code
- MSX – System, Network And Communication, Physiological Monitors
- Quantity
- two units
- Distribution
- Nationwide Distribution including OH and GA
- Recalling firm
- Mindray DS USA, Inc. d.b.a. Mindray North America, Mahwah, NJ