Mindray DS USA, Inc. dba Mindray North America: Device Recall

Recall Details

Recall Number

Z-2950-2024

Classification

Class II

Product Type

Device

Recalling Firm

Mindray DS USA, Inc. dba Mindray North America

Status

Ongoing

Date Initiated

07/22/2024

Location

Mahwah, NJ, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

96 units

Reason for Recall

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

Product Description

Sevoflurane E_Vap.(Safety Filling adapter) 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: 115-066756-00

Distribution Pattern

US Distribution to states of: California, Georgia, Kentucky, Mississippi, New Jersey, Puerto Rico, Texas, and West Virginia; and International (Foreign) to: Canada

Other Recalls by Mindray DS USA, Inc. dba Mindray North America

• Class II: Risk 11/18/2025
  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
  Potential for anesthesia leakage.
• Class II: Risk 10/20/2025
  Potential for anesthesia leakage.
• Class II: Risk 08/15/2025
  Potential for activation of an abnormal alarm pause.
• Class II: Risk 07/22/2024
  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 all recalls by Mindray DS USA, Inc. dba Mindray North America →