Mindray DS USA, Inc. dba Mindray North America Recalls

All product recalls associated with Mindray DS USA, Inc. dba Mindray North America.

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Recall Summary

Total Recalls

9

Past Year

4

Class I (Serious)

0

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–9 of 9 recalls

Hardware configuration of the BeneVision Central Monitori... (Mindray DS USA, Inc. dba Mindray North America) – when the worstation of the benevision... (2025)

When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may experience audio playback failure or screen freezing.

Moderate

FDANov 18, 2025Nationwide• Mindray DS USA, Inc. dba Mindray North America

Isoflurane V90 Vaporizer (Mindray) – Anesthesia Leakage Risk (2025)

Potential for anesthesia leakage.

Moderate

FDAOct 20, 2025Nationwide• Mindray DS USA, Inc. dba Mindray North America

Sevoflurane V90 Vaporizer (Mindray) – Anesthesia Leakage Risk (2025)

Potential for anesthesia leakage.

Moderate

FDA

Oct 20, 2025

Nationwide

• Mindray DS USA, Inc. dba Mindray North America

BeneVision N1 Patient Monitor (Mindray) – Alarm Pause Risk (2025)

Potential for activation of an abnormal alarm pause.

Moderate

FDAAug 15, 2025Nationwide• Mindray DS USA, Inc. dba Mindray North America

Mindray DS USA, Inc. dba Mindray North America: Isoflurane E_Vap.(Safety Filling adapter): used with the ...

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

Moderate

FDAJul 22, 2024CA, GA, KY +6 more• Mindray DS USA, Inc. dba Mindray North America

Mindray DS USA, Inc. dba Mindray North America: Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia ...

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

Moderate

FDAJul 22, 2024CA, GA, KY +6 more• Mindray DS USA, Inc. dba Mindray North America

Mindray DS USA, Inc. dba Mindray North America: Desflurane E_Vap.(Saf-T-Fill) used with the A9 Anesthesia...

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

Moderate

FDAJul 22, 2024CA, GA, KY +6 more• Mindray DS USA, Inc. dba Mindray North America

Mindray DS USA, Inc. dba Mindray North America: Sevoflurane E_Vap.(Safety Filling adapter) used with the ...

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

Moderate

FDAJul 22, 2024CA, GA, KY +6 more• Mindray DS USA, Inc. dba Mindray North America

Mindray DS USA, Inc. dba Mindray North America: Mindray BeneVision Distributed Monitoring System( DMS) 1....

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

Moderate

FDAFeb 22, 2021Nationwide• Mindray DS USA, Inc. dba Mindray North America

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Mindray DS USA, Inc. dba Mindray North America Recalls

Recall Summary

Hardware configuration of the BeneVision Central Monitori... (Mindray DS USA, Inc. dba Mindray North America) – when the worstation of the benevision... (2025)

Isoflurane V90 Vaporizer (Mindray) – Anesthesia Leakage Risk (2025)

Sevoflurane V90 Vaporizer (Mindray) – Anesthesia Leakage Risk (2025)

BeneVision N1 Patient Monitor (Mindray) – Alarm Pause Risk (2025)

Mindray DS USA, Inc. dba Mindray North America: Isoflurane E_Vap.(Safety Filling adapter): used with the ...

Mindray DS USA, Inc. dba Mindray North America: Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia ...

Mindray DS USA, Inc. dba Mindray North America: Desflurane E_Vap.(Saf-T-Fill) used with the A9 Anesthesia...

Mindray DS USA, Inc. dba Mindray North America: Sevoflurane E_Vap.(Safety Filling adapter) used with the ...

Mindray DS USA, Inc. dba Mindray North America: Mindray BeneVision Distributed Monitoring System( DMS) 1....