Mindray DS USA, Inc. dba Mindray North America

Complete recall history across all FDA and CPSC categories — 39 total recalls

Mindray DS USA, Inc. dba 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 (39)

FDA medical device enforcement actions by Mindray DS USA, Inc. dba Mindray North America

Date Product Reason Class
Nov 18, 2025 Hardware configuration of the BeneVision Central Monitoring System (CMS), mar... When the Worstation of the BeneVision DMS has a specific hardware configurati... Class II
Oct 20, 2025 Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labe... Potential for anesthesia leakage. Class II
Oct 20, 2025 Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. La... Potential for anesthesia leakage. Class II
Aug 15, 2025 BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA0001... Potential for activation of an abnormal alarm pause. Class II
Jul 22, 2024 Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to provi... V90 electronic vaporizer anesthetic agent output may be higher than the set a... Class II
Jul 22, 2024 Isoflurane E_Vap.(Safety Filling adapter): used with the A9 Anesthesia System... V90 electronic vaporizer anesthetic agent output may be higher than the set a... Class II
Jul 22, 2024 Desflurane E_Vap.(Saf-T-Fill) used with the A9 Anesthesia System-Used to prov... V90 electronic vaporizer anesthetic agent output may be higher than the set a... Class II
Jul 22, 2024 Sevoflurane E_Vap.(Safety Filling adapter) used with the A9 Anesthesia System... V90 electronic vaporizer anesthetic agent output may be higher than the set a... Class II
May 27, 2021 3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Tele... Telepack may not power on when using the 3AA battery cradle. Class III
Feb 22, 2021 Mindray BeneVision Distributed Monitoring System( DMS) 1. p/n 115-051209-00 ... BeneVision DMS may intermittently freeze and require a manual reboot after wh... Class II
Jan 13, 2020 DP-30 Digital Ultrasonic Diagnostic Imaging System, Part No. 1155E-PA00004 - ... The DP-30 displays an incorrect needle-guide bracket when used with the 65EC1... Class II
Dec 9, 2019 BA-800M Chemistry Analyzer Part Numbers BA81E-PA00002 and BA81E-PA00003, Cont... The gas spring on the front and rear protective cover may fail. There is a l... Class II
Dec 9, 2019 ABS800 Chemistry Analyzer Part Number BA81F-PA00001, Containing Gas spring YQ... The gas spring on the front and rear protective cover may fail. There is a l... Class II
Oct 1, 2019 Accutorr 7 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679... NIBP valve assembly board subject to this recall includes enhancements that a... Class II
Oct 1, 2019 Rosie4 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00,... NIBP valve assembly board subject to this recall includes enhancements that a... Class II
Oct 1, 2019 Rosebud Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00... NIBP valve assembly board subject to this recall includes enhancements that a... Class II
Oct 1, 2019 Accutorr 3 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679... NIBP valve assembly board subject to this recall includes enhancements that a... Class II
Aug 30, 2018 Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00 The firm has identified performance anomalies with the device caused when mor... Class II
Jan 24, 2018 Hematology Diluent M-53D used with BC-5390 Hematology Analyzer; Part Number: ... Certain lots of M-30D diluent used with BC-3200 and BC-3600 Hematology Analyz... Class II
Jan 24, 2018 Hematology Diluent M-30D used with BC-3200 and BC-3600 Hematology Analyzer; P... Certain lots of M-30D diluent used with BC-3200 and BC-3600 Hematology Analyz... Class II
Dec 1, 2017 Gas Module 3 monitoring spirometer, Part Number: 115-030108-00 Product Usa... The firm made multiple changes to the product requiring the submission of a n... Class III
Jul 14, 2017 TD60 Transmitter battery charger used with the BeneVision Central Station, Pa... A damaged circuit board in the battery charger can cause the battery to overc... Class II
Jul 14, 2017 A-Series A3/A5 Anesthesia Delivery System; Model Numbers: 0633F-01000-0X (A3)... A software issue may result in the previous settings being applied instead of... Class II
Jul 14, 2017 A-Series A7 Anesthesia Delivery System; Model Number: 0632F-PA0000X (A7) ... A software issue may result in the previous settings being applied instead of... Class II
Apr 28, 2017 TI Transport Monitor/Module Battery Pack Product Usage: intended for moni... Mindray has received two reports from outside the United States that the batt... Class II
Sep 8, 2016 TD60 display Telemetry Transmitter, SHENZHEN Mindray Bio-Medical Electronics ... Mindray has become aware that the TD60 Display Telemetry Transmitter used wit... Class II
Jun 23, 2016 Mindray DS USA Inc., Passport Series Patient Monitor intended for monitoring,... Mindray has identified a potential leakage issue with the CO2 Module's Drylin... Class II
Jun 15, 2016 A7 Anesthesia Delivery System, a device used to administer to a patient, cont... Potential for a leak to occur on the back-up O2 and air e-size cylinder yokes... Class II
Mar 9, 2016 Panorama Patient Monitoring Network Mindray DS USA The Panorama Patient Mo... Panorama Central Station including the work station View Station, View Statio... Class II
Dec 15, 2015 Panorama Patient Monitoring Network. Software Kit 0020-00-0205-19A, View S... An issue with the Panorama Central Station may cause the system to spontaneou... Class II
Jul 27, 2015 Mindray DPM 7 Monitor, Multi Parameter Patient Monitor (with Arrhythmia Detec... The DPM 7 Monitors may display a black screen. Class II
Mar 12, 2015 Panorama Patient Monitoring Network, Multi- Parameter Patient Monitor (with A... Software anomaly in the Panorama System software version 8.9 that manifests w... Class II
Jan 23, 2015 Passport V Monitor, Multiparameter Patient Monitor(with Arrhythmia Detection ... An issue has been identified with Passport V Monitors invasive blood pressure... Class II
Oct 6, 2014 DPM 6 Patient Monitor and DPM 7 Patient Monitor. The product affected is the... Mindray has identified an issue that involves the IBP module used with the DP... Class II
Jul 31, 2014 Mindray V21, Size: 515 mm X 335 mm X 685 mm, N.W.: 8 kg, G.W.: 11 kg, Qty:1 ... Mindray DS USA Inc. initiated a voluntary field corrective action for V-Serie... Class II
May 19, 2014 V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc. ... ECG interpretation feature issues. False measurements reported when the algo... Class II
Mar 5, 2014 DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor us... The MPM included a cardiac ST/Arrhythmia analysis feature which is not cleare... Class II
Jan 8, 2014 Panaroma Central Station Product Usage: This device can view real time,... Mindray has identified two issues with the Panorama Central Station. Full Dis... Class II
Oct 7, 2013 Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) P... Mindray has identified an issue with V Series Monitor where the V Dock power ... 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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