Mindray Ds Usa recalls
Mindray Ds Usa appears in 47 official U.S. recall notices indexed by RecallRadar, most recently on 2026-10-14.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 47 |
|---|---|
| Published | 2013-12-04 to 2026-10-14 |
| By agency | FDA Device (47) |
| By classification | Class II (37), Class III (10) |
| By status | terminated (30), ongoing (17) |
| Distribution named in notices | AL, CA, CO, CT, FL, GA, IA, IL, IN, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, PA, PR, SC, SD, TX, US, UT, VA, WA, WV, WY |
Recalls
- T1 Patient Monitor
FDA Device · Class III · 2026-10-14 · Mindray Ds Usa
Reason: Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions - BeneVision Series Telemetry Monitor
FDA Device · Class III · 2026-10-14 · Mindray Ds Usa
Reason: Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions - BeneVision N1 and N-Series Patient Monitor
FDA Device · Class III · 2026-10-14 · Mindray Ds Usa
Reason: Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions - cPM Series Patient Monitor
FDA Device · Class III · 2026-10-14 · Mindray Ds Usa
Reason: Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions - ePM Series Patient Monitor
FDA Device · Class III · 2026-10-14 · Mindray Ds Usa
Reason: Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions - Passport Series Patient Monitor
FDA Device · Class III · 2026-10-14 · Mindray Ds Usa
Reason: Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions - BeneView Series
FDA Device · Class III · 2026-10-14 · Mindray Ds Usa
Reason: Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions - Panorama and Telemetry Monitoring System
FDA Device · Class III · 2026-10-14 · Mindray Ds Usa
Reason: Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions - Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Distributed Monitoring System (DMS). Model…
FDA Device · Class II · 2025-12-24 · Mindray Ds Usa
Reason: When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may experience audio playback failure or screen freezing. - Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System
FDA Device · Class II · 2025-12-03 · Mindray Ds Usa
Reason: Potential for anesthesia leakage. - Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System
FDA Device · Class II · 2025-12-03 · Mindray Ds Usa
Reason: Potential for anesthesia leakage. - BeneVision N1 Patient Monitor (N1)
FDA Device · Class II · 2025-10-01 · Mindray Ds Usa
Reason: Potential for activation of an abnormal alarm pause. - Sevoflurane E_Vap.(Safety Filling adapter) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with control…
FDA Device · Class II · 2024-09-11 · Mindray Ds Usa
Reason: V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will… - Isoflurane E_Vap.(Safety Filling adapter): used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with control…
FDA Device · Class II · 2024-09-11 · Mindray Ds Usa
Reason: V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will… - Desflurane E_Vap.(Saf-T-Fill) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concent…
FDA Device · Class II · 2024-09-11 · Mindray Ds Usa
Reason: V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will… - Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentr…
FDA Device · Class II · 2024-09-11 · Mindray Ds Usa
Reason: V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will… - 3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Telepack (Model Number 115-047566-00 /115-060044-00) and TM80 Tele…
FDA Device · Class III · 2021-07-28 · Mindray Ds Usa
Reason: Telepack may not power on when using the 3AA battery cradle. - Mindray BeneVision Distributed Monitoring System( DMS) 1. p/n 115-051209-00 2. p/n 115-034414-00 and 115-034413-00 when used with the follo…
FDA Device · Class II · 2021-03-24 · Mindray Ds Usa
Reason: BeneVision DMS may intermittently freeze and require a manual reboot after which normal operation resumes. If a freeze occur, patients monitored on a telemetry transmitter will no longer communicate data to the BeneVisi… - DP-30 Digital Ultrasonic Diagnostic Imaging System, Part No. 1155E-PA00004 - Product Usage: The Digital Ultrasonic Diagnostic Imaging Syste…
FDA Device · Class II · 2020-02-26 · Mindray Ds Usa
Reason: The DP-30 displays an incorrect needle-guide bracket when used with the 65EC10EA model transducer. - ABS800 Chemistry Analyzer Part Number BA81F-PA00001, Containing Gas spring YQ-8/18-90-272-180N (Material Code M6T-010001--- (front spring))…
FDA Device · Class II · 2020-02-05 · Mindray Ds Usa
Reason: The gas spring on the front and rear protective cover may fail. There is a low risk of injury to the user resulting from failure of the gas spring. Injury may include impact to the arms, hands or fingers. - BA-800M Chemistry Analyzer Part Numbers BA81E-PA00002 and BA81E-PA00003, Containing Gas spring YQ-8/18-90-272-180N (Material Code M6T-01000…
FDA Device · Class II · 2020-02-05 · Mindray Ds Usa
Reason: The gas spring on the front and rear protective cover may fail. There is a low risk of injury to the user resulting from failure of the gas spring. Injury may include impact to the arms, hands or fingers. - Accutorr 7 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The mo…
FDA Device · Class II · 2019-11-06 · Mindray Ds Usa
Reason: NIBP valve assembly board subject to this recall includes enhancements that are not included in the current marketing clearance:1. Anti-motion feature 2. NIBP hose blockage identification function - Rosebud Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monit…
FDA Device · Class II · 2019-11-06 · Mindray Ds Usa
Reason: NIBP valve assembly board subject to this recall includes enhancements that are not included in the current marketing clearance:1. Anti-motion feature 2. NIBP hose blockage identification function - Rosie4 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monito…
FDA Device · Class II · 2019-11-06 · Mindray Ds Usa
Reason: NIBP valve assembly board subject to this recall includes enhancements that are not included in the current marketing clearance:1. Anti-motion feature 2. NIBP hose blockage identification function - Accutorr 3 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The mo…
FDA Device · Class II · 2019-11-06 · Mindray Ds Usa
Reason: NIBP valve assembly board subject to this recall includes enhancements that are not included in the current marketing clearance:1. Anti-motion feature 2. NIBP hose blockage identification function - Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00
FDA Device · Class II · 2018-10-24 · Mindray Ds Usa
Reason: The firm has identified performance anomalies with the device caused when more than 64 TD60 telemetry transmitters have been connected to a central station. The anomaly causes some ECG waveforms to appear as a flat line… - Hematology Diluent M-30D used with BC-3200 and BC-3600 Hematology Analyzer
FDA Device · Class II · 2018-04-18 · Mindray Ds Usa
Reason: Certain lots of M-30D diluent used with BC-3200 and BC-3600 Hematology Analyzers and M-53D diluent used with BC-5390 Hematology Analyzers may cause the system to produce an elevated platelet background count. - Hematology Diluent M-53D used with BC-5390 Hematology Analyzer
FDA Device · Class II · 2018-04-18 · Mindray Ds Usa
Reason: Certain lots of M-30D diluent used with BC-3200 and BC-3600 Hematology Analyzers and M-53D diluent used with BC-5390 Hematology Analyzer may cause the system to produce an elevated platelet background count. - Gas Module 3 monitoring spirometer, Part Number: 115-030108-00 Product Usage: The Gas Module 3 is an accessory device designed to monitor a…
FDA Device · Class III · 2018-04-04 · Mindray Ds Usa
Reason: The firm made multiple changes to the product requiring the submission of a new 510(k) premarket notification. - A-Series A3/A5 Anesthesia Delivery System
FDA Device · Class II · 2018-03-14 · Mindray Ds Usa
Reason: A software issue may result in the previous settings being applied instead of the default settings or the unit may skip the startup leak test. - A-Series A7 Anesthesia Delivery System
FDA Device · Class II · 2018-03-14 · Mindray Ds Usa
Reason: A software issue may result in the previous settings being applied instead of the default settings or the unit may skip the startup leak test. - TD60 Transmitter battery charger used with the BeneVision Central Station, Part number 115-030108-00
FDA Device · Class II · 2018-02-14 · Mindray Ds Usa
Reason: A damaged circuit board in the battery charger can cause the battery to overcharge and the battery case to swell and separate. - TI Transport Monitor/Module Battery Pack Product Usage: intended for monitoring, displaying, reviewing, storing, alarming and transferring…
FDA Device · Class II · 2017-07-05 · Mindray Ds Usa
Reason: Mindray has received two reports from outside the United States that the battery pack for TI transport monitor/module overheated. - TD60 display Telemetry Transmitter, SHENZHEN Mindray Bio-Medical Electronics Co., LTD, Mindray Building, Keji 12th Road South, Hi-Tech Indu…
FDA Device · Class II · 2016-11-09 · Mindray Ds Usa
Reason: Mindray has become aware that the TD60 Display Telemetry Transmitter used with the BeneVision Central Station may crack on the bezel surrounding the display and also the transmitter may not power on or will power on but… - A7 Anesthesia Delivery System, a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic an…
FDA Device · Class II · 2016-09-07 · Mindray Ds Usa
Reason: Potential for a leak to occur on the back-up O2 and air e-size cylinder yokes on the A7 Anesthesia Delivery System. - Mindray DS USA Inc., Passport Series Patient Monitor intended for monitoring, displaying, reviewing, alarming, and transferring of multiple…
FDA Device · Class II · 2016-08-24 · Mindray Ds Usa
Reason: Mindray has identified a potential leakage issue with the CO2 Module's Dryline II Water Trap used with the Passport Series Patient Monitor. - Panorama Patient Monitoring Network Mindray DS USA The Panorama Patient Monitoring can view recal time, store, print, graph and trend patie…
FDA Device · Class II · 2016-05-04 · Mindray Ds Usa
Reason: Panorama Central Station including the work station View Station, View Station and the eGateway will revert to the year 2000 when Daylight Savings Time (DST) occurs on March 13, 2016, or under various conditions. - Panorama Patient Monitoring Network
FDA Device · Class II · 2016-02-10 · Mindray Ds Usa
Reason: An issue with the Panorama Central Station may cause the system to spontaneously restart. This may occur after about 49 days of continuous operation. On restart, monitoring will be lost for about 2.5 minutes. Settings a… - Mindray DPM 7 Monitor, Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Intended to be used for monitoring, displayin…
FDA Device · Class II · 2015-09-16 · Mindray Ds Usa
Reason: The DPM 7 Monitors may display a black screen. - Panorama Patient Monitoring Network, Multi- Parameter Patient Monitor (with Arrhythmia Detection and Alarm
FDA Device · Class II · 2015-06-03 · Mindray Ds Usa
Reason: Software anomaly in the Panorama System software version 8.9 that manifests when the Panorama is in use with Mindray Passport V Monitor. Arrhythmia alarms which were previously displayed on both the Passport V and Panor… - Passport V Monitor, Multiparameter Patient Monitor(with Arrhythmia Detection and Alarms) Intended for intra hospital use under the direct s…
FDA Device · Class II · 2015-03-25 · Mindray Ds Usa
Reason: An issue has been identified with Passport V Monitors invasive blood pressure function (IBP) which may provide an incorrect IBP measurement - DPM 6 Patient Monitor and DPM 7 Patient Monitor
FDA Device · Class II · 2014-12-31 · Mindray Ds Usa
Reason: Mindray has identified an issue that involves the IBP module used with the DPM 6 and DPM 7 Monitor where the IBP measurement data may be displayed in an incorrect IBP tile on the monitors display. - Mindray V21, Size: 515 mm X 335 mm X 685 mm, N.W.: 8 kg, G.W.: 11 kg, Qty:1 The V-Series Monitor is intended for intra hospital use under t…
FDA Device · Class II · 2014-10-29 · Mindray Ds Usa
Reason: Mindray DS USA Inc. initiated a voluntary field corrective action for V-Series Patient Monitor because there is an issue with the V-Series Drug Calculator function. - V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc
FDA Device · Class II · 2014-07-23 · Mindray Ds Usa
Reason: ECG interpretation feature issues. False measurements reported when the algorithm cannot determine P wave or QRS axis. The Median Complex Report displays the representative beat 25% larger than actual signal input. When… - DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used for monitoring, displaying, reviewing, storing, and alarming…
FDA Device · Class II · 2014-05-21 · Mindray Ds Usa
Reason: The MPM included a cardiac ST/Arrhythmia analysis feature which is not cleared for marketing. - Panaroma Central Station Product Usage: This device can view real time, store, print, graph, and trend patient clinical and demographic data
FDA Device · Class II · 2014-03-19 · Mindray Ds Usa
Reason: Mindray has identified two issues with the Panorama Central Station. Full Disclosure data may lag behind the Panorama system time clock when the Panorama Central Station is in use with Mindray¿s V-Series Monitor. Additi… - Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Product Usage: The V Series Monitor is intended for intra hospital u…
FDA Device · Class II · 2013-12-04 · Mindray Ds Usa
Reason: Mindray has identified an issue with V Series Monitor where the V Dock power pins connecting the V Series Monitor to the V Dock may lose spring tension, potentially causing the screen to temporarily go blank, lose commu…