Z-0630-2013 Class II Terminated
FDA device recall Z-0630-2013 was initiated by Mindray DS USA, Inc. d.b.a. Mindray North America on May 12, 2011 and is designated Class II. 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. The recall status is terminated (terminated February 19, 2013). Affected quantity: two units.
Recall Details
- Product Type
- Devices
- Report Date
- January 9, 2013
- Initiation Date
- May 12, 2011
- Termination Date
- February 19, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- two units
Product Description
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.
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.
Distribution Pattern
Nationwide Distribution including OH and GA
Code Information
510 K K080192 P/N 300BF-PA200002