Recall archive / FDA device enforcement
Isoflurane E_Vap.(Safety Filling adapter): used with the A9 Anesthesia System-Used to provide the vapor of an anesthe... — FDA record Z-2951-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 22, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- 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
- Classification
- Class II
- Recalling firm
- Mindray DS USA, Inc. dba Mindray North America
- Quantity
- 24 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2951-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 06936415975753 Serial Number: AH6B24000165 AH6B24000170 AH6B24000167 AH6B24000163 AH6B24000166 AH6B24000173 AH6B24000174 AH6B24000183 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Distribution to states of: California, Georgia, Kentucky, Mississippi, New Jersey, Puerto Rico, Texas, and West Virginia; and International (Foreign) to: Canada
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Sep 11, 2024
- Recall initiation date
- Jul 22, 2024
- Center classification date
- Sep 4, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.