Mindray recalls Isoflurane E_Vap Safety Filling Adapters used with A9 Anesthesia Systems due to potential over-delivery of anesthetic. Patients may experience drowsiness or neurological issues if overdose occurs.
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 Isoflurane E_Vap Safety Filling Adapters that can deliver too much anesthetic to patients during surgery. This risk could cause drowsiness, vertigo, or neurological problems after the procedure.
The adapter's seal may become incomplete, causing the anesthetic to be delivered at a higher concentration than set. This can lead to patients inhaling too much anesthetic, resulting in drowsiness, vertigo, or neurological issues after surgery.
Healthcare professionals using the A9 Anesthesia System with the recalled adapters. Patients undergoing anesthesia are at risk if the adapter malfunctions.
Check for part number 115-066758-00 or serial numbers starting with AH6B24000163 to AH6B24000183 on the adapter. These adapters are used with the A9 Anesthesia System.
Look for serial numbers starting with AH6B24000163 to AH6B24000183 on the adapter.
Reach out to Mindray North America for further instructions on handling the recalled adapter.
Yes, the adapter may deliver too much anesthetic, causing drowsiness, vertigo, or neurological issues after surgery.
Check the serial number to see if it's recalled. Contact Mindray North America for instructions.
Recalled adapters have part number 115-066758-00 and serial numbers starting with AH6B24000163 to AH6B24000183.
We’ve drafted a message you can send Mindray to request your refund or repair — edit it as you like.
Subject: Recall Z-2951-2024 — Mindray Mindray Hello, I own a Mindray that is covered by recall Z-2951-2024 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.