Mindray Ds Usa D B A Mindray North America recalls
Mindray Ds Usa D B A Mindray North America appears in 9 official U.S. recall notices indexed by RecallRadar, most recently on 2013-04-03.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 9 |
|---|---|
| Published | 2012-09-05 to 2013-04-03 |
| By agency | FDA Device (9) |
| By classification | Class II (7), Class I (2) |
| By status | terminated (9) |
| Distribution named in notices | NC, TX, US |
Recalls
- BS-200 Chemistry Analyzer Designed for clinical laboratory use
FDA Device · Class II · 2013-04-03 · Mindray Ds Usa D B A Mindray North America
Reason: An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate. - Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack
FDA Device · Class II · 2013-02-20 · Mindray Ds Usa D B A Mindray North America
Reason: Mindray has identified a software anomaly that may where, in the presence of an asystole, the Telepack ECG waveform may produce a unique step pattern (instead of a flat line) if Lead 1 or V is being utilized for detecti… - Mindray DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities
FDA Device · Class II · 2013-02-06 · Mindray Ds Usa D B A Mindray North America
Reason: Mindray has identified an issue with the DPM5 monitors where ST and Arrhythmia features may not be available. - 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 · 2013-01-09 · Mindray Ds Usa D B A Mindray North America
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. - Mindray V12 Size: 320 mm X 320 mm X 450 mm N.W.: 3 kg G.W.: 6 kg Qty:1 Manufactured in China Mindray V21 Size: 515 mm X 335 mm X 685 mm N.W…
FDA Device · Class II · 2012-12-26 · Mindray Ds Usa D B A Mindray North America
Reason: Mindray has identified an issue with the V Series Monitor where the monitors touch screen may stop responding to touch. - DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd
FDA Device · Class II · 2012-12-19 · Mindray Ds Usa D B A Mindray North America
Reason: There is an issue with the DPM 6 and DPM 7 monitors where the following features may be unavailable : Full Disclosure, Drug, Hemodynamic Calculations, Renal Calculations, Oxygenation Calculations, and Ventilation Calcul… - Mindray A5 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 This is a dev…
FDA Device · Class I · 2012-11-28 · Mindray Ds Usa D B A Mindray North America
Reason: Mindray has identified the potential for a system leak resulting an issue related to the carbon dioxide absorber canister gasket on A3/A5 Anesthesia Delivery Systems. A potential system leak resulting from the canister… - Mindray A3 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 This is a dev…
FDA Device · Class I · 2012-11-28 · Mindray Ds Usa D B A Mindray North America
Reason: Mindray has identified the potential for a system leak resulting an issue related to the carbon dioxide absorber canister gasket on A3/A5 Anesthesia Delivery Systems. A potential system leak resulting from the canister… - V Series Patient Monitors
FDA Device · Class II · 2012-09-05 · Mindray Ds Usa D B A Mindray North America
Reason: Mindray has identified two software anomalies contained in the V Series Monitoring System. There have been no reports of injuries associated with these anomalies. These anomalies affect V Series Systems distributed betw…