Mindray DS USA, Inc. dba Mindray North America 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 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Mindray DS USA, Inc. dba Mindray North America
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
UDI-DI: 06936415975777 Serial Number: AH6A28000471 AH6A24000202 AH6A28000474 AH6A27000378 AH6A28000466 AH6A24000195 AH6A28000457 AH6A25000237 AH6A28000426 AH6A24000199 AH6A24000207
Mindray DS USA, Inc. dba Mindray North America is recalling Sevoflurane E_Vap.(Safety Filling adapter) used with the A9 Anesthesia System-Used to provide the va due to V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
Mindray issued an "URGENT Medical Device Recall" letter on July 22, 2024. Letter states reason for recall, health risk and actions to be taken: The V90 electronic vaporizer can continue to be used normally. If "Vaporizer Output Abnormal" alarm or other alarms associated with abnormal vaporizer output or high anesthetic agent alarms occur during use, take appropriate intervention per the A9 Operators manual and contact Mindray Technical Support for assistance. The intervention could be switching to another V90 electronic vaporizer, or the user can decide to switch to intravenous anesthesia. For vaporizer replacement, refer to A9 Operators manual part number H-046-017199-00, section 3.4. Vaporizer . The manual is available on the Mindray website. Mindray s Technical Support team can assist and may be reached at (877) 913-9663 (Option 1) Monday through Friday, 8:30 a.m. 5:30 p.m. ET. Please ensure that applicable clinical staff are aware of the content of this letter. Mindray will replace all affected V90 electronic vaporizers located at your facility. The V90 electronic vaporizers will be shipped directly to your facility, and a Mindray Care Team representative will contact you to schedule the installation and collect the affected V90 electronic vaporizers Contact: Director, Quality Operations and Regulatory Affairs US Agent for Shenzhen Mindray Biomedical Electronics Corp., Ltd Mindray DS USA, Inc. 201.995.8407
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, GA, KY, MS, NJ, TX, VA, WV, PR
Page updated: Jan 10, 2026