Mindray DS USA, Inc.
FDA adverse event reports naming Mindray DS USA, Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: MINDRAY DS USA, INC..
- Total reports
- 2,353
- Deaths
- 10
- Injuries
- 7
- Malfunctions
- 2,292
Reports per year
Source: FDA adverse event reports by year received, 2009–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Top device categories
- Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)MHX1,852
- Gas-Machine, AnesthesiaBSZ180
- Detector And Alarm, ArrhythmiaDSI104
- Spirometer, Monitoring (W/Wo Alarm)BZK74
- System, Measurement, Blood-Pressure, Non-InvasiveDXN58
- Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)DRT51
- System, Network And Communication, Physiological MonitorsMSX17
- Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)MWI4
- Analyzer, Gas, Carbon-Dioxide, Gaseous-PhaseCCK3
- Transducer, Ultrasonic, DiagnosticITX2
Recent recalls
- 2026-10-07Open, ClassifiedLabeling design
ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
- 2026-10-07Open, ClassifiedLabeling design
BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22.
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
- 2026-10-07Open, ClassifiedLabeling design
BeneVision Series Telemetry Monitor. Operator's Manuals: TM70/TM80
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
- 2026-10-07Open, ClassifiedLabeling design
Panorama and Telemetry Monitoring System. Operator's Manuals: TMS-6016/Panorama Telepack-608/TMS60 (TD60).
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
- 2026-10-07Open, ClassifiedLabeling design
BeneView Series. Operator's Manuals: T5 / T8
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
- 2026-10-07Open, ClassifiedLabeling design
Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
- 2026-10-07Open, ClassifiedLabeling design
cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
- 2026-10-07Open, ClassifiedLabeling design
T1 Patient Monitor. Operator's Manual: T1 Patient Monitor
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
- 2025-12-12Open, ClassifiedSoftware design
Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Distributed Monitoring System (DMS). Model Number: 115-050935-00 and E115-050935-00. Software Version: Audio Driver version 6.0.9484.1 HP Pro Mini 400 G9 Desktop PC with Realtek HD Audio Driver Officially Released by HP (audio driver version 6.0.9484.1)
When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may experience audio playback failure or screen freezing.
- 2025-11-26Open, ClassifiedDevice Design
Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Sev E_Vap. (Safety Filling adapter), Part Number: 115-066756-00. 2. Exchange Sev E_Vap. (Safety Filling adapter), Part Number: E115-066756-00. Product Description: The Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The A9 Anesthesia System utilizes V90 electronic vaporizers for anesthetic agent delivery.
Potential for anesthesia leakage.
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