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Mindray DS USA, Inc. d.b.a. Mindray North America

Complete recall history across all FDA and CPSC categories — 9 total recalls

Mindray DS USA, Inc. d.b.a. Mindray North America appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (9)

FDA medical device enforcement actions by Mindray DS USA, Inc. d.b.a. Mindray North America

Date Product Reason Class
Nov 28, 2012 Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack.... Mindray has identified a software anomaly that may where, in the presence of ... Class II
Nov 28, 2012 BS-200 Chemistry Analyzer Designed for clinical laboratory use. An issue has been identified with the BS-200 where clinical chemistry results... Class II
Sep 24, 2012 Mindray V12 Size: 320 mm X 320 mm X 450 mm N.W.: 3 kg G.W.: 6 kg Qty:1 Manuf... Mindray has identified an issue with the V Series Monitor where the monitors ... Class II
Sep 5, 2012 Mindray DPM5 Monitor, a vital signs monitor used on human patients in health... Mindray has identified an issue with the DPM5 monitors where ST and Arrhythmi... Class II
Aug 13, 2012 Mindray A3 Anesthesia Delivery System Manufactured in China for Mindray DS ... Mindray has identified the potential for a system leak resulting an issue rel... Class I
Aug 13, 2012 Mindray A5 Anesthesia Delivery System Manufactured in China for Mindray DS ... Mindray has identified the potential for a system leak resulting an issue rel... Class I
May 7, 2012 V Series Patient Monitors; Mindray DS USA, Inc. Product Usage: The V Seri... Mindray has identified two software anomalies contained in the V Series Monit... Class II
May 12, 2011 DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ... There is a software anomaly with the DPM Central Monitoring System where the ... Class II
Aug 11, 2010 DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. ... There is an issue with the DPM 6 and DPM 7 monitors where the following featu... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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