Mindray DS USA, Inc. dba Mindray North America

FDA Regulatory Profile

Summary

Total Recalls
39
510(k) Clearances
0
Inspections
7
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0920-2026Class IIHardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision DisNovember 18, 2025
Z-0720-2026Class IISevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following:October 20, 2025
Z-0721-2026Class IIIsoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: October 20, 2025
Z-2622-2025Class IIBeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA00014, 6660E-PA00012, 6660EAugust 15, 2025
Z-2949-2024Class IISevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to provide the vapor of an anesJuly 22, 2024
Z-2952-2024Class IIDesflurane E_Vap.(Saf-T-Fill) used with the A9 Anesthesia System-Used to provide the vapor of an aneJuly 22, 2024
Z-2950-2024Class IISevoflurane E_Vap.(Safety Filling adapter) used with the A9 Anesthesia System-Used to provide the vaJuly 22, 2024
Z-2951-2024Class IIIsoflurane E_Vap.(Safety Filling adapter): used with the A9 Anesthesia System-Used to provide the vaJuly 22, 2024
Z-2108-2021Class III3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Telepack (Model Number 115-May 27, 2021
Z-1254-2021Class IIMindray BeneVision Distributed Monitoring System( DMS) 1. p/n 115-051209-00 2. p/n 115-034414-00 aFebruary 22, 2021
Z-1330-2020Class IIDP-30 Digital Ultrasonic Diagnostic Imaging System, Part No. 1155E-PA00004 - Product Usage: The DigiJanuary 13, 2020
Z-0921-2020Class IIABS800 Chemistry Analyzer Part Number BA81F-PA00001, Containing Gas spring YQ-8/18-90-272-180N (MateDecember 9, 2019
Z-0920-2020Class IIBA-800M Chemistry Analyzer Part Numbers BA81E-PA00002 and BA81E-PA00003, Containing Gas spring YQ-8/December 9, 2019
Z-0236-2020Class IIAccutorr 7 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing softwarOctober 1, 2019
Z-0235-2020Class IIAccutorr 3 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing softwarOctober 1, 2019
Z-0238-2020Class IIRosebud Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software vOctober 1, 2019
Z-0237-2020Class IIRosie4 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software veOctober 1, 2019
Z-0170-2019Class IIMindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00August 30, 2018
Z-1321-2018Class IIHematology Diluent M-53D used with BC-5390 Hematology Analyzer; Part Number: 105-007867-00 (20L contJanuary 24, 2018
Z-1320-2018Class IIHematology Diluent M-30D used with BC-3200 and BC-3600 Hematology Analyzer; Part Numbers: (1) 105-00January 24, 2018