FDA Device recall Z-2952-2024
Desflurane E_Vap.(Saf-T-Fill) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concent…
- FDA Device
- Class II
- ongoing
- Published 2024-09-11
On 2024-09-11 the FDA classified a Class II recall of Desflurane E_Vap.(Saf-T-Fill) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concent… 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-2952-2024 |
| 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
Desflurane E_Vap.(Saf-T-Fill) 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 Number115-066759-00
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:06936415975760 Serial Number: AH6C25000263 AH6C25000255 AH6C27000355 AH6C27000346 AH6C27000371 AH6C25000256 AH6…UDI-DI:06936415975760 Serial Number: AH6C25000263 AH6C25000255 AH6C27000355 AH6C27000346 AH6C27000371 AH6C25000256 AH6C25000296 AH6C25000290 AH6C27000361 AH6C25000254 AH6C25000254 AH6C25000271 AH6C25000298 AH6C25000299 AH6C25000300 AH6C25000301 AH6C25000302 AH6C27000339 AH6C27000343 AH6C27000344 AH6C27000347 AH6C27000348 AH6C27000350 AH6C27000352 AH6C27000354 AH6C27000358 AH6C27000359 AH6C27000363 AH6C27000364 AH6C27000366 AH6C27000410 AH6C27000411 AH6C28000444 AH6C28000447 AH6C28000448 AH6C28000449 AH6C28000450 AH6C28000454 |
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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-2952-2024%22
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