# FDA recall Z-2950-2024

> **Mindray DS USA, Inc. dba Mindray North America** · Class II · device recall initiated 2024-07-22.

## Product

Sevoflurane 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: 115-066756-00

## 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

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

## Key facts

- **Recall number:** Z-2950-2024
- **Recalling firm:** Mindray DS USA, Inc. dba Mindray North America
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-07-22
- **Report date:** 2024-09-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mahwah, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2950-2024

## Citation

> AI Analytics. FDA recall Z-2950-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2950-2024. Source: US FDA. Licensed CC0.

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