Class 2 Device Recall Mindray

• Date Initiated by Firm: July 22, 2024
• Date Posted: September 04, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2951-2024
• Recall Event ID: 95099
• 510(K)Number: K201957
• Product Classification: Gas-machine, anesthesia - Product Code BSZ
• Product: Isoflurane 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: Part Number 115-066758-00
• Code Information: UDI-DI: 06936415975753 Serial Number: AH6B24000165 AH6B24000170 AH6B24000167 AH6B24000163 AH6B24000166 AH6B24000173 AH6B24000174 AH6B24000183
• Recalling Firm/ Manufacturer: Mindray DS USA, Inc. dba Mindray North America; 800 Macarthur Blvd; Mahwah NJ 07430-2001
• For Additional Information Contact: SAME; 800-288-2121
• Manufacturer 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
• FDA Determined Cause: Nonconforming Material/Component
• Action: 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
• Quantity in Commerce: 24 units
• Distribution: US Distribution to states of: California, Georgia, Kentucky, Mississippi, New Jersey, Puerto Rico, Texas, and West Virginia; and International (Foreign) to: Canada
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = BSZ