Mindray Ds Usa, Inc.
800 MACARTHUR BLVD., Mahwah, NJ, US
Registered product codes
59 product codes
Recent MDR events
2,978 on file
- BENEVISION N12 AND MPM MODULEOct 27, 2025InjuryMW5177989
- M9 ULTRASOUND SYSTEMJun 24, 2025Malfunction22318570
- MINDRAY ANESTHESIA MACHINE A7Feb 8, 2023InjuryMW5114824
- MINDRAY A7 ANESTHESIA MACHINEOct 25, 2022InjuryMW5112854
- MINDRAY 17M PATIENT MONITOR AND MINDRAY MPMFeb 22, 2022MalfunctionMW5107623
- DUAL CABLE PROBE GLB7Dec 23, 2021MalfunctionMW5106274
- MINDRAY A5 ADVANTAGE / ANESTHESIA DELIVERY UNITAug 21, 2020InjuryMW5096202
- MINDRAYDec 23, 2019InjuryMW5091875
- BENIVISION CENTRIAL STATION, TELEMETRYApr 27, 2018InjuryMW5076864
- BENIVISION CENTRAL STATION, TELEMETRYApr 27, 2018MalfunctionMW5076865
Recalls
56 on file
- Open, ClassifiedDec 12, 2025
When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may experience audio playback failure or screen freezing.
View FDA record ↗ - Open, ClassifiedNov 26, 2025
Potential for anesthesia leakage.
View FDA record ↗ - Open, ClassifiedNov 26, 2025
Potential for anesthesia leakage.
View FDA record ↗ - Open, ClassifiedSep 25, 2025
Potential for activation of an abnormal alarm pause.
View FDA record ↗ - Open, ClassifiedSep 4, 2024
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 anesthetic agent; the patient may suffer from symptoms such as vertigo and drowsiness after the operation. In severe cases, the patient may suffer from neurological sequelae such as hypomnesia and inattention
View FDA record ↗ - Open, ClassifiedSep 4, 2024
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 anesthetic agent; the patient may suffer from symptoms such as vertigo and drowsiness after the operation. In severe cases, the patient may suffer from neurological sequelae such as hypomnesia and inattention
View FDA record ↗ - Open, ClassifiedSep 4, 2024
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 anesthetic agent; the patient may suffer from symptoms such as vertigo and drowsiness after the operation. In severe cases, the patient may suffer from neurological sequelae such as hypomnesia and inattention
View FDA record ↗ - Open, ClassifiedSep 4, 2024
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 anesthetic agent; the patient may suffer from symptoms such as vertigo and drowsiness after the operation. In severe cases, the patient may suffer from neurological sequelae such as hypomnesia and inattention
View FDA record ↗ - TerminatedFeb 5, 2020
The DP-30 displays an incorrect needle-guide bracket when used with the 65EC10EA model transducer.
View FDA record ↗ - TerminatedJan 29, 2016
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.
View FDA record ↗
Compliance history
Matched by FEI 2221819.
FDA inspections
1 on file
- No Action Indicated (NAI)Feb 22, 2024
Compliance: Devices
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.