Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with co
Summary
The FDA issued a Class II for Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to provide by Mindray DS USA, Inc. dba Mindray North America. 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 .
Details
Source
Device Recall
External ID
Z-2949-2024
Action Date
2024-09-11
Status
Ongoing
Category
device
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
Lot/Code Info: UDI-DI: 06936415975784 Serial Number: AH6D28000517, AH6D28000518
Quantity Affected: 2 units
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
Type: Voluntary: Firm initiated
Recall Initiated: 2024-07-22
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 363 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Mindray DS USA, Inc. dba Mindray North America has 9 FDA actions in our database, including 9 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Mindray DS USA, Inc. dba Mindray North America) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Mindray DS USA, Inc. dba Mindray North America have FDA actions?
Mindray DS USA, Inc. dba Mindray North America has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2949-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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