Desflurane E_Vap.(Saf-T-Fill) used with the A9 Anesthesia System-Used to provide the vapor of an ...

FDA Device Recall #Z-2952-2024 — Class II — July 22, 2024

Recall Summary

Recall Number Z-2952-2024
Classification Class II — Moderate risk
Date Initiated July 22, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Mindray DS USA, Inc. dba Mindray North America
Location Mahwah, NJ
Product Type Devices
Quantity 96 units

Product Description

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 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

Distribution Pattern

US Distribution to states of: California, Georgia, Kentucky, Mississippi, New Jersey, Puerto Rico, Texas, and West Virginia; and International (Foreign) to: Canada

Lot / Code Information

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

Other Recalls from Mindray DS USA, Inc. dba Mindray Nort...

Recall # Classification Product Date
Z-0920-2026 Class II Hardware configuration of the BeneVision Centra... Nov 18, 2025
Z-0720-2026 Class II Sevoflurane (SEVO) V90 Electronic Vaporizer wit... Oct 20, 2025
Z-0721-2026 Class II Isoflurane (ISO) V90 Electronic Vaporizer with ... Oct 20, 2025
Z-2622-2025 Class II BeneVision N1 Patient Monitor (N1). Part Number... Aug 15, 2025
Z-2951-2024 Class II Isoflurane E_Vap.(Safety Filling adapter): used... Jul 22, 2024

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.