Data / Medical devices / United States / MINDRAY DS USA, Inc.

MINDRAY DS USA, Inc.: FDA-registered device maker in Mahwah, NJ, United States, 53 510(k) clearances

Name: MINDRAY DS USA, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

MINDRAY DS USA, Inc. is registered with the FDA (registration 2221819) in Mahwah, NJ, United States. It lists 60 device types. The FDA files 53 510(k) clearances under its listings, the newest dated August 28, 2025. 55 recall events name it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 2221819
Address: 800 Macarthur BLVD., Mahwah, NJ, United States, 07430
Owner or operator: Mindray DS USA, Inc. (10025908)
Roles: Complaint file establishment, Contract manufacturer
First device listed: February 25, 2013
Registered through: 2027
Brand names listed: A3 Anesthesia Delivery System, A4 Anesthesia System, A5 Anesthesia Delivery System, A5 Anesthesia System, A7 Anesthesia System, A8 Anesthesia Delivery System, A9 Anesthesia Delivery System, ACUSON Bonsai Diagnostic Ultrasound System and more

Devices it lists

Device	Product code	Class	Role	Source
Alarm, Blood-Pressure	DSJ	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Amplifier And Signal Conditioner, Transducer Signal	DRQ	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	1	Complaint file establishment	accessdata.fda.gov
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	CCK	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	NHO	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	CBQ	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	CBS	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	NHQ	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	CBR	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Analyzer, Gas, Oxygen, Gaseous-Phase	CCL	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	NHP	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Burst Suppression Detection Software For Electroencephalograph	ORT	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Calibrator For Cell Indices	KRX	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Calibrator For Hemoglobin And Hematocrit Measurement	KRZ	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Calibrator For Platelet Counting	KRY	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Calibrator For Red-Cell And White-Cell Counting	KSA	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Computer, Blood-Pressure	DSK	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Computer, Diagnostic, Pre-Programmed, Single-Function	DXG	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Continuous Measurement Thermometer	FLL	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Continuous, Minimal Ventilatory Support, Facility Use Ventilator	MNT	2	Contract manufacturer	accessdata.fda.gov
Counter, Differential Cell	GKZ	2	Complaint file establishment	accessdata.fda.gov
Detector And Alarm, Arrhythmia	DSI	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Detergent	JCB	1	Complaint file establishment	accessdata.fda.gov
Diluent, Blood Cell	GIF	1	Complaint file establishment	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Electrode, Ion Specific, Potassium	CEM	2	Complaint file establishment	accessdata.fda.gov
Electrode, Ion Specific, Sodium	JGS	2	Complaint file establishment	accessdata.fda.gov
Electrode, Ion-Specific, Chloride	CGZ	2	Complaint file establishment	accessdata.fda.gov
Gas-Machine, Anesthesia	BSZ	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Hexokinase, Glucose	CFR	2	Complaint file establishment	accessdata.fda.gov
Index-Generating Electroencephalograph Software	OLW	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Mixture, Hematology Quality Control	JPK	2	Complaint file establishment	accessdata.fda.gov
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	DRT	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	MWI	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	MHX	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Monitor, St Segment	MLC	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Monitor, St Segment With Alarm	MLD	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Non-Normalizing Quantitative Electroencephalograph Software	OLT	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Oximeter	DQA	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Oximeter, Ear	DPZ	2	Contract manufacturer	accessdata.fda.gov
Oximeter, Tissue Saturation	MUD	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Plethysmograph, Impedance	DSB	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Products, Red-Cell Lysing Products	GGK	1	Complaint file establishment	accessdata.fda.gov
Reduced- Montage Standard Electroencephalograph	OMC	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Regulator, Vacuum	KDP	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Stimulator, Nerve, Peripheral, Electric	KOI	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Complaint file establishment	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
System, Network And Communication, Physiological Monitors	MSX	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Table, Operating-Room, Ac-Powered	FQO	1	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Table, Surgical With Orthopedic Accessories, Ac-Powered	JEA	1	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Tester, Electrode, Surface, Electrocardiographic	KRC	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Transducer, Blood-Pressure, Extravascular	DRS	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Transmitters And Receivers, Physiological Signal, Radiofrequency	DRG	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Urease And Glutamic Dehydrogenase, Urea Nitrogen	CDQ	2	Complaint file establishment	accessdata.fda.gov
Vaporizer, Anesthesia, Non-Heated	CAD	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Ventilator, Continuous, Facility Use	CBK	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 28, 2025	K243767	SV600, SV800 Ventilator	CBK	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
May 30, 2025	K250024	TE Air Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
September 16, 2024	K241201	TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite/Anesus TEX20 Pro/Eagus TEX20/Eagus TEX20T/Eagus TEX21/Eagus TEX21T/Eros/TE X Plus/Anesus TEX10 Pro/TEX9U/TEX9M/Eagus TEX11/Eagus TEX11T/EagusTEX10/Eagus TEX10T/Eagus TEX/Ares Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
September 12, 2024	K241432	MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
June 17, 2024	K240684	Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9, Resona I9W, Recho I9, Recho I9 Pro, Recho I9 Exp, Recho I9S, Recho I9T Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
April 22, 2024	K240115	Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, NuewaI8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
June 9, 2023	K230768	M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
February 7, 2023	K222928	Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic Ultrasound Sysem, Nuewa R9 Pro/ Nuewa R9S/ Resona 7/ Resona 7CV/Resona 7EXP/Resona 7S/ Resona 70B Diagnostic Ultrasound System, Resona 7PRO/Imagyn 7/ Resona Y/Resona R9W/Resona R7W Nuewa R9W/Nuewa R7W Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
September 29, 2022	K221496	Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE, Consona AT, Consona N6 Exp Diagnostic Ultrasound System, Consona N6 Elite, Consona N6T Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
September 29, 2022	K221300	Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite, Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super, Consona OR, Consona N8S, Consona OI, Consona OT, Consona N8 Exp, Consona N8 Elite, Consona N8T, Consona N7, Consona N7 Pro, Consona N7 Super, Consona VR, Consona N7S, Consona VI, Consona VT, Consona N7 Exp, Consona N7 Elite, Consona N7T Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
July 12, 2022	K213799	N Series Patient Monitors	MHX	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
July 1, 2021	K211337	DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
March 23, 2021	K203391	TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
August 21, 2020	K201693	DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80AExp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
May 28, 2020	K200979	DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
April 8, 2020	K200411	Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
April 2, 2020	K200251	Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
December 19, 2019	K192410	ZS3 and z.one pro Ultrasound Systems	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
December 13, 2019	K192152	DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
July 10, 2019	K190011	Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)	MHX	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
April 9, 2019	K183660	DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
April 4, 2019	K183377	DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
March 27, 2019	K182821	Accutorr 7/VS-900/VS-900c Vital Signs Monitor	MWI	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
March 13, 2019	K183238	BeneVision Central Monitoring System	MSX	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
January 12, 2018	K171311	A5 Anesthesia System	BSZ	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
January 12, 2018	K171292	A7 Anesthesia System	BSZ	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
October 25, 2017	K172970	M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
October 18, 2017	K171579	M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
August 2, 2017	K170712	Accutorr 7/VS-900 Vital Signs Monitor	MWI	Substantially Equivalent	Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.	accessdata.fda.gov
July 10, 2017	K171034	M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System, M8 Elite Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
March 23, 2017	K170277	DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
September 1, 2016	K160606	BC-5D Hematology Control	JPK	Substantially Equivalent	R&D Systems, Inc.	accessdata.fda.gov
September 1, 2016	K160429	BC-5390 Auto Hematology Analyzer	GKZ	Substantially Equivalent	Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
June 9, 2016	K160370	BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer	JGS	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
March 3, 2016	K153448	Passport Series Patient Monitors (Including Passport 8, Passport 12)	MHX	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
August 21, 2015	K143348	BC-3600 Auto Hematology Analyzer	GKZ	Substantially Equivalent	Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
June 30, 2015	K150167	V60 Anesthetic Vaporizer	CAD	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
May 15, 2015	K151175	ZONARE ZS3 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Zonare Medical Systems, Inc.	accessdata.fda.gov
September 2, 2014	K140690	BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER	CDQ	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
February 19, 2014	K140030	DC-N3/DC-N3S DIAGNOSTIC ULTRASOUND SYSTEM	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
February 14, 2013	K123211	A5 ANESTHESIA DELIVERY SYSTEM	BSZ	Substantially Equivalent	Datascope Corp., Patient Monitoring Division	accessdata.fda.gov
April 19, 2012	K120699	DC-T6 DIAGNOSTIC ULTRASOUND SYSTEM	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
March 23, 2012	K112377	BS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZER	CFR	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
December 27, 2010	K103583	DC-7 DIAGNOSTIC ULTRASOUND SYSTEM	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
November 3, 2010	K102865	DC-7 DIAGNOSTIC ULTRASOUND SYSTEM, DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM	ITX	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
October 22, 2010	K102991	M5 DIAGNOSTIC ULTRASOUND SYSTEM	IYO	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
April 8, 2010	K093394	BC-3200 AUTO HEMATOLOGY ANALYZER,M-30D DILUENT, M-30R RINSE, M-30CFL LYSE, M-30E-Z CLEANSER, M-30PROBE CLEANSER, BC-3D C	GKZ	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
April 15, 2009	K090912	DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-6900	ITX	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
February 1, 2008	K072018	BS-200 CHEMISTRY ANALYZER, MODE BS-200	CFR	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
September 23, 2004	K042276	D-VAPOR	CAD	Substantially Equivalent	Draeger Medical, Inc.	accessdata.fda.gov
September 16, 1997	K971923	DRAGER-VAPOR 2000	CAD	Substantially Equivalent	Draeger Medical, Inc.	accessdata.fda.gov
February 29, 1996	K955925	CBC-CAL PLUS HEMATOLOGY CALIBRATOR	KRX	Substantially Equivalent	R&D Systems, Inc.	accessdata.fda.gov
November 1, 1984	K843962	CBC-PLT-4 WHOLE BLOOD CONTROL/MULTIPLE	JPK	Substantially Equivalent	R&D Systems, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
August 31, 2026	99828	Class III	Ongoing	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	accessdata.fda.gov
November 18, 2025	97969	Class II	Ongoing	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	When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may experience audio playback failure or screen freezing.	accessdata.fda.gov
October 20, 2025	97810	Class II	Ongoing	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), Pa	Potential for anesthesia leakage.	accessdata.fda.gov
August 15, 2025	97437	Class II	Ongoing	BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA00014, 6660E-PA00012, 6660E-PA00011, 6660E-PA00018, 6660E-PA00015, 6660E-PA00020, Q6660E-PA00011, 6660E-PA00021, 6660E-PA00016, 6660E-PA00019, Q666	Potential for activation of an abnormal alarm pause.	accessdata.fda.gov
July 22, 2024	95099	Class II	Ongoing	Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number 115-066755-00	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 generate alarms associated with abnormal vaporizer output. If the anesthetic concentration is too high, the patient can inhale too much anes	accessdata.fda.gov
May 27, 2021	88209	Class III	Terminated	3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Telepack (Model Number 115-047566-00 /115-060044-00) and TM80 Telepack (Model Number 115-047565-00 / 120-018867-00). Used with physiological data m	Telepack may not power on when using the 3AA battery cradle.	accessdata.fda.gov
February 22, 2021	87380	Class II	Ongoing	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 following software versions: 03.04.00 04.01.00 04.03.00 04.04.00 04.04.01	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 BeneVision DMS	accessdata.fda.gov
January 13, 2020	84794	Class II	Terminated	DP-30 Digital Ultrasonic Diagnostic Imaging System, Part No. 1155E-PA00004 - Product Usage: The Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It i	The DP-30 displays an incorrect needle-guide bracket when used with the 65EC10EA model transducer.	accessdata.fda.gov
December 9, 2019	84497	Class II	Terminated	BA-800M Chemistry Analyzer Part Numbers BA81E-PA00002 and BA81E-PA00003, Containing Gas spring YQ-8/18-90-272-180N (Material Code M6T-010001--- (front spring)) and Gas spring YQ6/15-84-235(B-B)-80N (033-000090-00 (rear s	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.	accessdata.fda.gov
October 1, 2019	83979	Class II	Terminated	Accutorr 3 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is intended for spot-check monitoring physiologic parameters, including Pul	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	accessdata.fda.gov
August 30, 2018	81084	Class II	Terminated	Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00	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 at the centralized viewing station and will manifest if more than 64 TD60 transmitters have been connected to a given central station server	accessdata.fda.gov
January 24, 2018	79556	Class II	Terminated	Hematology Diluent M-30D used with BC-3200 and BC-3600 Hematology Analyzer; Part Numbers: (1) 105-005405-00 (2 x 5.5L container), (2) 105-005406-00 (20L container) The M-30D Diluent is an azide-free, filtered isotonic so	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.	accessdata.fda.gov
December 1, 2017	79423	Class III	Terminated	Gas Module 3 monitoring spirometer, Part Number: 115-030108-00 Product Usage: The Gas Module 3 is an accessory device designed to monitor airway gases during anesthesia and/or assisted respiration. Monitored gases includ	The firm made multiple changes to the product requiring the submission of a new 510(k) premarket notification.	accessdata.fda.gov
July 14, 2017	79133	Class II	Terminated	A-Series A3/A5 Anesthesia Delivery System; Model Numbers: 0633F-01000-0X (A3) and 0631F-01000-0X (A5) Product Usage: The A-Series Anesthesia System is a device used to administer to a patient, continuously or intermitten	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.	accessdata.fda.gov
July 14, 2017	79005	Class II	Terminated	TD60 Transmitter battery charger used with the BeneVision Central Station, Part number 115-030108-00	A damaged circuit board in the battery charger can cause the battery to overcharge and the battery case to swell and separate.	accessdata.fda.gov
April 28, 2017	77390	Class II	Terminated	TI Transport Monitor/Module Battery Pack Product Usage: intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters.	Mindray has received two reports from outside the United States that the battery pack for TI transport monitor/module overheated.	accessdata.fda.gov
September 8, 2016	75062	Class II	Terminated	TD60 display Telemetry Transmitter, SHENZHEN Mindray Bio-Medical Electronics Co., LTD, Mindray Building, Keji 12th Road South, Hi-Tech Industrial Partk, Nanshan, Shenzhen, 518057 P.R. China	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 display an error message.	accessdata.fda.gov
June 23, 2016	74704	Class II	Terminated	Mindray DS USA Inc., Passport Series Patient Monitor intended for monitoring, displaying, reviewing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12-lead selectable, ar	Mindray has identified a potential leakage issue with the CO2 Module's Dryline II Water Trap used with the Passport Series Patient Monitor.	accessdata.fda.gov
June 15, 2016	74758	Class II	Terminated	A7 Anesthesia Delivery System, a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. Part numbers 0632F-PA0000X (US domestic) a	Potential for a leak to occur on the back-up O2 and air e-size cylinder yokes on the A7 Anesthesia Delivery System.	accessdata.fda.gov
March 9, 2016	73693	Class II	Terminated	Panorama Patient Monitoring Network Mindray DS USA The Panorama Patient Monitoring can view recal time, store, print, graph and trend patient clinical and demographic data. The Panoram Patient Monitoring Network can sent	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.	accessdata.fda.gov
December 15, 2015	72864	Class II	Terminated	Panorama Patient Monitoring Network. Software Kit 0020-00-0205-19A, View Station Software Kit 0020-00-0206-16A, Work Station Software Kit 0020-00-0207-16A, Software Kit Upgrade TECH-00-910. The Panaroma Patient Monitorin	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 and configurations are maintained.	accessdata.fda.gov
July 27, 2015	71934	Class II	Terminated	Mindray DPM 7 Monitor, Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including	The DPM 7 Monitors may display a black screen.	accessdata.fda.gov
March 12, 2015	70959	Class II	Terminated	Panorama Patient Monitoring Network, Multi- Parameter Patient Monitor (with Arrhythmia Detection and Alarm. Part number 0998-00-0708-01. The Panorama Network includes the Panorama Telemetry System, which acquires and mon	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 Panorama will not be displayed on the Panorama following a restart of either system (due to communication loss, restart, etc.).	accessdata.fda.gov
January 23, 2015	70546	Class II	Terminated	Passport V Monitor, Multiparameter Patient Monitor(with Arrhythmia Detection and Alarms) Intended for intra hospital use under the direct supervision of a licensed healthcare practitioner.	An issue has been identified with Passport V Monitors invasive blood pressure function (IBP) which may provide an incorrect IBP measurement	accessdata.fda.gov
October 6, 2014	69788	Class II	Terminated	DPM 6 Patient Monitor and DPM 7 Patient Monitor. The product affected is the Mindray IBP module, P/N is 6800-30-50485 for use with Mindray DPM 6 and DPM 7 patient monitors. Intended to be used for monitoring, displaying,	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.	accessdata.fda.gov
July 31, 2014	69260	Class II	Terminated	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 the direct supervision of a licensed healthcare practitioner. The indications for	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.	accessdata.fda.gov
May 19, 2014	68582	Class II	Terminated	V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc. Used for monitoring of human physiological parameters. The V-Series Monitor also has the capability of performing IV Drug and Hemodynamic Calculat	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 a patient date of birth is imported from an external source, the ECG interpretation algorithm uses the default age of 50, and interpretive s	accessdata.fda.gov
March 5, 2014	67932	Class II	Terminated	DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used for monitoring, displaying, reviewing, storing, and alarming of multiple physiological parameters including ECG, arrhythmia detection, ST seg	The MPM included a cardiac ST/Arrhythmia analysis feature which is not cleared for marketing.	accessdata.fda.gov
January 8, 2014	67495	Class II	Terminated	Panaroma Central Station Product Usage: This device can view real time, store, print, graph, and trend patient clinical and demographic data. The device can also set independent alarm limits for data send by the bedside	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 Mindrays V-Series Monitor. Additionally, event indicators lag behind the Panorama system time clock when the Panorama Central Station is in use with a Panorama Telepack.	accessdata.fda.gov
October 7, 2013	66755	Class II	Terminated	Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Product Usage: The V Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indica	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 communication with the central station monitor (when one is in use) or shut down. No patient related events have been reported to Mindray concerni	accessdata.fda.gov
November 28, 2012	64114	Class II	Terminated	Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002, and 300BF-PA00003 (DPM Central Monitoring System) 115-006908-01, -03, -04 (DPM software upgrade kit). The DPM Cen	Mindray has identified a software anomaly that may where, in the presence of an asystole, the Telepack ECG waveform may produce a unique step pattern (instead of a flat line) if Lead 1 or V is being utilized for detecting cardiac arrhythmia.	accessdata.fda.gov
November 28, 2012	64112	Class II	Terminated	BS-200 Chemistry Analyzer Designed for clinical laboratory use.	An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate.	accessdata.fda.gov
September 24, 2012	63652	Class II	Terminated	Mindray V12 Size: 320 mm X 320 mm X 450 mm N.W.: 3 kg G.W.: 6 kg Qty:1 Manufactured in China Mindray V21 Size: 515 mm X 335 mm X 685 mm N.W.: 8 kg G.W.: 11 kg Qty:1 Manufactured in China One product, V Series monitor, av	Mindray has identified an issue with the V Series Monitor where the monitors touch screen may stop responding to touch.	accessdata.fda.gov
September 5, 2012	63800	Class II	Terminated	Mindray DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities.	Mindray has identified an issue with the DPM5 monitors where ST and Arrhythmia features may not be available.	accessdata.fda.gov
August 13, 2012	63314	Class I	Terminated	Mindray A3 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 This is a device used to administer to a patient continuously or intermittently a general inha	Mindray has identified the potential for a system leak resulting an issue related to the carbon dioxide absorber canister gasket on A3/A5 Anesthesia Delivery Systems. A potential system leak resulting from the canister gasket will likely present itself during the Automatic Circuit Leak and Compliance Test performed at startup and the Manual Leak Test recomme	accessdata.fda.gov
May 7, 2012	62880	Class II	Terminated	V Series Patient Monitors; Mindray DS USA, Inc. Product Usage: The V Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for Use for the V	Mindray has identified two software anomalies contained in the V Series Monitoring System. There have been no reports of injuries associated with these anomalies. These anomalies affect V Series Systems distributed between September 31, 2010 and January 9, 2012.	accessdata.fda.gov
October 14, 2011	60976	Not yet classified	Terminated	V Series Monitor Mindray DS USA, Inc. 800 MacArthur Boulevard. Mahwah, NJ 07430 The Indications for Use for the V Series include the monitoring of the following human physiological parameters: ECG waveform derived from 3	A system database corruption may occur that causes the V Series Monitor to reset.	accessdata.fda.gov
May 12, 2011	63616	Class II	Terminated	DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows	There is a software anomaly with the DPM Central Monitoring System where the trend data of one patient maybe replaced with the trend data of a second patient.	accessdata.fda.gov
August 11, 2010	63614	Class II	Terminated	DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430 USA. Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological	There is an issue with the DPM 6 and DPM 7 monitors where the following features may be unavailable : Full Disclosure, Drug, Hemodynamic Calculations, Renal Calculations, Oxygenation Calculations, and Ventilation Calculations.	accessdata.fda.gov
April 28, 2010	55572	Not yet classified	Terminated	Passport V Monitor: Mindray, North America. Mindray DS USA, Inc. Mahwah, NJ 07430. Intended for intra hospital use under the direct supervision of a healthcare practitioner for the monitoring of various human physiologic	An issue with the Passport V Monitor has been identified where the Arrhythmia Analysis, ST Analysis and Invasive Blood Pressure functions are not operational.	accessdata.fda.gov
March 5, 2010	54851	Not yet classified	Terminated	Datascope AS3000 Anesthesia System; Mindray, North America. The AS3000 Anesthesia Delivery System is a continuous flow inhalation gas anesthesia system that delivers anesthetic vapor, provides for automatic and manual mo	An issue affecting the caster mount on the AS3000 System have been identified, specifically reports of the caster mount breaking, causing the wheel to fall off and the unit to tip.	accessdata.fda.gov
December 31, 2009	54175	Not yet classified	Terminated	SmarTemp Probe Covers with the Accutorr V Monitor; Rx only. Mindray DS USA, Inc. Mahway, NJ 07430. Packaged in boxes of 20, Model ST010, also distributed in boxes of 2000 (10 individual boxes of 200); SmarTemp Module Kit	SmarTemp Disposable Probe covers may contain microscopic holes in the molded seam that would allow liquids or body fluids inside the cover and potentially contaminate the temperature probe.	accessdata.fda.gov
April 10, 2009	51863	Not yet classified	Terminated	Panorama Patient Monitoring Network with ambulatory telepacks, and software version 8.5.5, 8.5.6, 8.6.1 or 8.7. Datascope Patient Monitoring Intended for use in a fixed location, in the healthcare facility setting, as a	Software Anomaly: Software anomaly can occur when the Panorama is attempting to play an audio file, either a physiological or technical alarm sound, at which time the system software may cause the system to freeze due to an interaction in the alarm system.	accessdata.fda.gov
October 7, 2008	49713	Not yet classified	Terminated	AS3000 Anesthesia Delivery System. Datascope Patient Monitoring; A Mindray Global Company. The AS3000 is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to ma	Two issues have been identified with the AS3000 unit. 1. The threadlocker of the caster (wheels) may not have been utilized, which may allow the caster to loosen and possibly separate from the unit. 2. The use of select brands of pre-pack absorber in the absorber canister of the AS3000 has been associated, in some cases, with gas leakage around the pre-pack,	accessdata.fda.gov
November 19, 2007	45957	Not yet classified	Terminated	Datascope CS 100 Intra-Aortic Balloon Pump and Datascope CS 300 Intra-Aortic Balloon Pump, Datascope Corp. Mahwah, NJ 07430	Defective Circuit Board -- A defect in the Printed Circuit Board's (PCB) in the CS 100 and CS300 Intra-Aortic Balloon Pump may cause the pump to exhibit intermittent malfunctions, which include failure to start-up or reset of the display screen during therapy.	accessdata.fda.gov
March 17, 2006	35059	Not yet classified	Terminated	Anestar and Anestar Plus Anesthesia System.	The Anestar and Anestar Plus Anesthesia System may produce periods of high Positive End-Expiratory Pressure (PEEP), in both manual and mechanical ventilation mode due to an issue with the Applied Pressure Limit (APL) valve.	accessdata.fda.gov
December 7, 2005	34320	Not yet classified	Terminated	Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor.	Software anomaly that affects the Panorama Telepack where if communications are lost during standby, certain alarms which appear set could be actually off.	accessdata.fda.gov
September 7, 2005	33724	Not yet classified	Terminated	Spectrum Patient Monitor, Physiological, Patient with arrhythmia detection or alamrs. Monitor can monitor, display, trend and print a patient''s physiological parameters. The device has a 12.1 inch color display and has	Software anomalies which include shut down while printing, invalid diastolic blood pressure display, and incomplete and inaccurate interpretation reports of 12-Lead ECG data.	accessdata.fda.gov
August 19, 2005	33230	Not yet classified	Terminated	Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor.	The software version contains an anomaly which could freeze the unit when the right click button is used on the mouse.	accessdata.fda.gov
June 16, 2005	32617	Not yet classified	Terminated	Panorama Patient Monitoring Network. Cardiac Arrhythmia Monitor.	Upon the new release of software, the firm started receiving reports of unexpected system failures in the database subsystem related to virtual memory pages.	accessdata.fda.gov
September 24, 2004	30145	Not yet classified	Terminated	Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm).	Software anomaly where the variable heart rates may be displayed inaccurately or intermittent 'dashes' may be displayed when the patient's heart rate is derived from ECG.	accessdata.fda.gov
July 28, 2004	29941	Not yet classified	Terminated	Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm).	The Trio Monitor has latex feet. It is not labeled per 21 CFR801.437 to indicate that it contains latex.	accessdata.fda.gov
April 5, 2004	29424	Not yet classified	Terminated	Passport 2/Passport 2 LT Vital Signs Monitor. Multi-parameter patient monitoring system.	Potential inaccurate printed information in the upper and lower margins of a print strip.	accessdata.fda.gov
December 30, 2003	28388	Not yet classified	Terminated	HemaCarotid Patch, Ultrathin, Collagen Coated Knitted Polyester Vascular Patch. Product Catalog Numbers: HEK06/75CPUT; HEK08/75CPUT; HEK14/75CPUT; HEK08/120CPUT; HEK10/75CPUT; HEK25/100CPUT; HEK12/75CPUT; HEK10/150CPUT.	Water permeability of the patch is out of specification.	accessdata.fda.gov
June 24, 2003	29545	Not yet classified	Terminated	Anestar Anesthesia Delivery System	Failure of the Anestar AC Main Power Switch. Battery should last 30 minutes, then ventilation and monitoring will fail.	accessdata.fda.gov

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Updated October 7, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.