Recall Z-2949-2024— Mindray DS USA, Inc. dba Mindray North America

Name: FDA recall Z-2949-2024
Creator: U.S. Food and Drug Administration
Published: 2024-07-22

Class II · Ongoing

Class II FDA medical device recall by Mindray DS USA, Inc. dba Mindray North America, initiated 2024-07-22. It names one FDA 510(k) clearance: K201957. Product: Sevoflurane E_Vap.(Quik-Fil):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 115-066755-00. 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.

Recalling firm: Mindray DS USA, Inc. dba Mindray North America
Classification: Class II
Status: Ongoing
Initiated: 2024-07-22
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K201957 — A8, A9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.·cleared 2021-03-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Sevoflurane E_Vap.(Quik-Fil):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 115-066755-00

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.