Mindray DS USA, Inc. dba Mindray North America

8 FDA enforcement actions

8 Total Recalls

0 Class I

8 Class II

0 Class III

Firm Details

Product Types: device
States: NJ

All Recalls

Class II: Risk 11/18/2025 device

When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may experience audio playback failure or screen freezing.
Class II: Risk 10/20/2025 device

Potential for anesthesia leakage.
Class II: Risk 10/20/2025 device

Potential for anesthesia leakage.
Class II: Risk 08/15/2025 device

Potential for activation of an abnormal alarm pause.
Class II: Risk 07/22/2024 device

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
Class II: Risk 07/22/2024 device

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
Class II: Risk 07/22/2024 device

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
Class II: Risk 07/22/2024 device

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

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.