Data Foundry

Medical device recalls 2013

DPM Central Station Mindray DS USA — Class II medical device recall Z-0630-2013

Terminated recall by Mindray DS USA, Inc. d.b.a. Mindray North America, reported 2013-01-09, distributed nationwide. There is a software anomaly with the DPM Central Monitoring System where the trend data of one patient maybe r

Recall numberZ-0630-2013
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmMindray DS USA, Inc. d.b.a. Mindray North America, Mahwah, NJ, United States
Recall initiated2011-05-12
Classified2013-01-03
Reported by FDA2013-01-09
Terminated2013-02-19
DistributedNationwide (US)
Reason classessoftware

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 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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0630-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.