Z-2949-2024Class II

Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic...

Name: Z-2949-2024 Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic...
Creator: Mindray DS USA, Inc. dba Mindray North America
Published: 2024-07-22
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2024-07-22 / Open, Classified / root cause: manufacturing process

FDA source

Mindray DS USA, Inc. dba Mindray North America began a recall of 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... on 2024-07-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2949-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-07-22
Posted: 2024-09-04
Recalling firm: Datascope Corp.
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
Product code: BSZ Gas-Machine, Anesthesia
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
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Mindray issued an "URGENT Medical Device Recall" letter on July 22, 2024. Letter states reason for recall, health risk and actions to be taken: The V90 electronic vaporizer can continue to be used normally. If "Vaporizer Output Abnormal" alarm or other alarms associated with abnormal vaporizer output or high anesthetic agent alarms occur during use, take appropriate intervention per the A9 Operators manual and contact Mindray Technical Support for assistance. The intervention could be switching to another V90 electronic vaporizer, or the user can decide to switch to intravenous anesthesia. For vaporizer replacement, refer to A9 Operators manual part number H-046-017199-00, section 3.4. Vaporizer . The manual is available on the Mindray website. Mindray s Technical Support team can assist and may be reached at (877) 913-9663 (Option 1) Monday through Friday, 8:30 a.m. 5:30 p.m. ET. Please ensure that applicable clinical staff are aware of the content of this letter. Mindray will replace all affected V90 electronic vaporizers located at your facility. The V90 electronic vaporizers will be shipped directly to your facility, and a Mindray Care Team representative will contact you to schedule the installation and collect the affected V90 electronic vaporizers Contact: Director, Quality Operations and Regulatory Affairs US Agent for Shenzhen Mindray Biomedical Electronics Corp., Ltd Mindray DS USA, Inc. 201.995.8407
Quantity in commerce: 2 units
Distribution: US Distribution to states of: California, Georgia, Kentucky, Mississippi, New Jersey, Puerto Rico, Texas, and West Virginia; and International (Foreign) to: Canada
Product codes and lots: UDI-DI: 06936415975784 Serial Number: AH6D28000517, AH6D28000518

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2949-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2949-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-11	2024-09-04
Z-2950-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-11	2024-09-04
Z-2951-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-11	2024-09-04
Z-2952-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-11	2024-09-04

Product code BSZ

K201957Class IIA8, A9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. / cleared 2021-03-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)