Mindray DS USA, Inc. dba Mindray North America: Medical Device Recall in 2024 - (Recall #: Z-2951-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 22, 2024

Date Posted: September 11, 2024

Recall Number: Z-2951-2024

Event ID: 95099

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

Status: Ongoing

Product Quantity: 24 units

Code Information:

UDI-DI: 06936415975753 Serial Number: AH6B24000165 AH6B24000170 AH6B24000167 AH6B24000163 AH6B24000166 AH6B24000173 AH6B24000174 AH6B24000183

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated