FDA Device recall Z-0630-2013
DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers i…
- FDA Device
- Class II
- terminated
- Published 2013-01-09
On 2013-01-09 the FDA classified a Class II recall of DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers i… by Mindray Ds Usa D B A Mindray North America, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0630-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2011-05-12 |
| Published | 2013-01-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Mindray Ds Usa D B A Mindray North America |
| Distribution | US |
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.
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.
Identifiers
| code_info | 510 K K080192 P/N 300BF-PA200002 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0630-2013%22
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