The Recall Desk

Manufacturer

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

9 recalls in our database name Mindray DS USA, Inc. d.b.a. Mindray North America as the manufacturing or recalling firm.

What the numbers show

Total
9
Critical
0
Severe
0
Most recent
2013-04-03

Of the 9 recalls from Mindray DS USA, Inc. d.b.a. Mindray North America we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–9 of 9

  • HighFDA (Devices)·Z-0977-2013·2013-04-03

    Mindray BS-200 Chemistry Analyzer Recalled for Inaccurate Clinical Results

    Mindray is recalling three BS-200 Chemistry Analyzers because clinical chemistry results may be inaccurate. The units were distributed in North Carolina and Texas.

    Product
    BS-200 Chemistry Analyzer Designed for clinical laboratory use.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0798-2013·2013-02-20

    Mindray DPM Central Monitoring System Recalled for ECG Waveform Anomaly

    Mindray is recalling 51 DPM Central Monitoring Systems because a software anomaly may display a step pattern instead of a flat line during asystole.

    Product
    Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002, and 300BF-PA00003 (DPM Central Monitoring System) 115-006908-01, -03, -04 (DPM software upgrade kit). The DPM Central Monitoring System transfers information between DPM Cen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0742-2013·2013-02-06

    Mindray Recalls DPM5 Monitors Due to Missing ST and Arrhythmia Features

    Mindray is recalling 13 DPM5 vital signs monitors because ST and Arrhythmia features may not be available.

    Product
    Mindray DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0630-2013·2013-01-09

    Mindray DPM Central Station Recalled for Patient Data Anomaly

    Mindray is recalling two DPM Central Station units due to a software anomaly that may replace one patient's trend data with another's.

    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 connec
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0528-2013·2012-12-26

    Mindray Recalls V Series Patient Monitors Due to Touchscreen Malfunction

    Mindray is recalling V Series patient monitors because the touchscreens may stop responding to touch.

    Product
    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.: 8 kg G.W.: 11 kg Qty:1 Manufactured in China One product, V Series monitor, available in two sizes: The V12 has a 12 inch screen,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0513-2013·2012-12-19

    Mindray Recalls DPM 6 and 7 Patient Monitors for Software Limitations

    Mindray DS USA is recalling 124 DPM 6 and 7 patient monitors because specific calculation features may be unavailable.

    Product
    DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430 USA. Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-le
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0291-2013·2012-11-28

    Mindray A5 Anesthesia Delivery System Recalled for Potential System Leak

    Mindray is recalling A5 Anesthesia Delivery Systems due to a potential system leak caused by a carbon dioxide absorber canister gasket issue.

    Product
    Mindray A5 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 This is a device used to administer to a patient continuously or intermittently a general inhalation anesthetic and to maintain a patient's ventilati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0290-2013·2012-11-28

    Mindray A3 Anesthesia Delivery System Recalled for Potential System Leak

    Mindray is recalling 69 A3 Anesthesia Delivery Systems due to a potential system leak caused by a carbon dioxide absorber canister gasket issue.

    Product
    Mindray A3 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 This is a device used to administer to a patient continuously or intermittently a general inhalation anesthetic and to maintain a patient's ventila
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2279-2012·2012-09-05

    Mindray Recalls V Series Patient Monitors Due to Software Anomalies

    Mindray is recalling 979 V Series Patient Monitors worldwide due to two identified software anomalies. No injuries have been reported.

    Product
    V Series Patient Monitors; Mindray DS USA, Inc. Product Usage: The V Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for Use for the V Series include the monitoring of the following human ph
    Category
    Medical Device
    Distribution
    Distributed nationwide