FDA Device recall Z-2949-2024
Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentr…
- FDA Device
- Class II
- ongoing
- Published 2024-09-11
On 2024-09-11 the FDA classified a Class II recall of Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentr… by Mindray Ds Usa, citing 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 is….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2949-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-07-22 |
| Published | 2024-09-11 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Mindray Ds Usa |
| Distribution | CA, GA, KY, MS, NJ, PR, TX, WV |
Product
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
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
Identifiers
| code_info | UDI-DI: 06936415975784 Serial Number: AH6D28000517, AH6D28000518 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2949-2024%22
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