Recall Z-2949-2024 ยท BSZ Gas-Machine, Anesthesia
Mindray DS USA, Inc. dba Mindray North America
Sevoflurane E_Vap.(Quik-Fil):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 115-066755-00
| Date | Sep 4, 2024 (initiated Jul 22, 2024) |
| Status | Open, Classified |
| Reason | 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 |
| Root 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. F |
| Quantity | 2 units |
| Distribution | US Distribution to states of: California, Georgia, Kentucky, Mississippi, New Jersey, Puerto Rico, Texas, and West Virginia; and International (Foreign) to: Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201957 | A8, A9 Anesthesia System Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Mar 26, 2021 |