Mindray recalls Sevoflurane E_Vap Quik-Fil used with A9 Anesthesia System due to potential overdose risk from inaccurate anesthetic delivery. Patients may experience drowsiness or neurological issues if anesthetic concentration is too high.
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
Mindray is recalling Sevoflurane E_Vap Quik-Fil anesthesia vaporizers that may deliver too much anesthetic. This could cause drowsiness or neurological problems after surgery if the device malfunctions.
The vaporizer may not seal properly, causing the anesthetic to be delivered at a higher concentration than set. This can lead to patients inhaling too much anesthetic, causing drowsiness or neurological issues after surgery.
Healthcare professionals using the A9 Anesthesia System with this specific vaporizer model are most at risk. Patients undergoing anesthesia with this device may experience side effects if the vaporizer malfunctions.
Check for the part number 115-066755-00 or serial numbers AH6D28000517 and AH6D28000518 on the device. This product was sold with the A9 Anesthesia System.
Verify if the vaporizer has the part number 115-066755-00 or serial numbers AH6D28000517 or AH6D28000518.
The product may deliver too much anesthetic, causing drowsiness or neurological issues. It is not safe to use without checking the part number or serial number.
The recall does not specify a remedy, so check the part number or serial number to confirm if it is affected.
The recall states that in severe cases, patients may suffer neurological issues, but the remedy is not specified.
We’ve drafted a message you can send Mindray to request your refund or repair — edit it as you like.
Subject: Recall Z-2949-2024 — Mindray Mindray Hello, I own a Mindray that is covered by recall Z-2949-2024 from Mindray. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
