Mindray DS USA, Inc. dba Mindray North America
Summary
- Total Recalls
- 39
- 510(k) Clearances
- 0
- Inspections
- 7
- Compliance Actions
- 1
Known Names
mindray ds usa, inc. dba mindray north america, mindray ds usa, inc. d.b.a. mindray north america
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0920-2026 | Class II | Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Dis | November 18, 2025 |
| Z-0720-2026 | Class II | Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: | October 20, 2025 |
| Z-0721-2026 | Class II | Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: | October 20, 2025 |
| Z-2622-2025 | Class II | BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA00014, 6660E-PA00012, 6660E | August 15, 2025 |
| Z-2949-2024 | Class II | Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to provide the vapor of an anes | July 22, 2024 |
| Z-2952-2024 | Class II | Desflurane E_Vap.(Saf-T-Fill) used with the A9 Anesthesia System-Used to provide the vapor of an ane | July 22, 2024 |
| Z-2950-2024 | Class II | Sevoflurane E_Vap.(Safety Filling adapter) used with the A9 Anesthesia System-Used to provide the va | July 22, 2024 |
| Z-2951-2024 | Class II | Isoflurane E_Vap.(Safety Filling adapter): used with the A9 Anesthesia System-Used to provide the va | July 22, 2024 |
| Z-2108-2021 | Class III | 3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Telepack (Model Number 115- | May 27, 2021 |
| Z-1254-2021 | Class II | Mindray BeneVision Distributed Monitoring System( DMS) 1. p/n 115-051209-00 2. p/n 115-034414-00 a | February 22, 2021 |
| Z-1330-2020 | Class II | DP-30 Digital Ultrasonic Diagnostic Imaging System, Part No. 1155E-PA00004 - Product Usage: The Digi | January 13, 2020 |
| Z-0921-2020 | Class II | ABS800 Chemistry Analyzer Part Number BA81F-PA00001, Containing Gas spring YQ-8/18-90-272-180N (Mate | December 9, 2019 |
| Z-0920-2020 | Class II | BA-800M Chemistry Analyzer Part Numbers BA81E-PA00002 and BA81E-PA00003, Containing Gas spring YQ-8/ | December 9, 2019 |
| Z-0236-2020 | Class II | Accutorr 7 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing softwar | October 1, 2019 |
| Z-0235-2020 | Class II | Accutorr 3 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing softwar | October 1, 2019 |
| Z-0238-2020 | Class II | Rosebud Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software v | October 1, 2019 |
| Z-0237-2020 | Class II | Rosie4 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software ve | October 1, 2019 |
| Z-0170-2019 | Class II | Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00 | August 30, 2018 |
| Z-1321-2018 | Class II | Hematology Diluent M-53D used with BC-5390 Hematology Analyzer; Part Number: 105-007867-00 (20L cont | January 24, 2018 |
| Z-1320-2018 | Class II | Hematology Diluent M-30D used with BC-3200 and BC-3600 Hematology Analyzer; Part Numbers: (1) 105-00 | January 24, 2018 |