The Recall Desk

FDA (Devices) recall action 95099

Mindray DS USA, Inc. dba Mindray North America recalled 4 products on 2024-09-11

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2024-09-11
Critical
0
Units
218

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–4 of 4

  • HighFDA (Devices)··2024-09-11

    Desflurane anesthesia vaporizer recalled for possible excessive anesthetic output

    Mindray's Desflurane E_Vap vaporizer may deliver anesthetic at higher concentrations than set due to an incomplete seal. Patients could inhale excessive anesthetic, potentially causing dizziness, drowsiness, and in severe cases, neurological effects.

    Product
    Desflurane E_Vap.(Saf-T-Fill) 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: Part Number115-066759-00
    Category
    Distribution
    8 states
  • HighFDA (Devices)··2024-09-11

    Sevoflurane Vaporizer for A9 Anesthesia System Recalled for Output Malfunction

    Mindray recalled 2 Sevoflurane E_Vap vaporizers used in A9 Anesthesia Systems due to a component defect causing excessive anesthetic output. The defect risks patient anesthetic overdose with potential neurological effects including post-operative vertigo and drowsiness.

    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
    Category
    Distribution
    8 states
  • HighFDA (Devices)··2024-09-11

    Anesthesia Vaporizer Adapter May Deliver Excessive Anesthetic Concentration

    Sevoflurane vaporizer adapters used with Mindray A9 anesthesia systems may deliver higher-than-set anesthetic concentrations due to incomplete sealing. Patients could inhale excessive anesthetic, potentially causing drowsiness, vertigo, or in severe cases, neurological effects.

    Product
    Sevoflurane E_Vap.(Safety Filling adapter) 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: 115-066756-00
    Category
    Distribution
    8 states
  • HighFDA (Devices)··2024-09-11

    Anesthesia System Vaporizer Adapter Recalled for Potential Anesthetic Overdose

    Mindray's Isoflurane E_Vap adapter for the A9 Anesthesia System is recalled due to a seal defect that may cause higher-than-intended anesthetic concentration delivery. Twenty-four units were distributed to eight U.S. states and Canada.

    Product
    Isoflurane E_Vap.(Safety Filling adapter): 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: Part Number 115-066758-00
    Category
    Distribution
    8 states