The Recall Desk

FDA (Devices) recall action 80209

Draeger Medical, Inc. recalled 5 products on 2018-06-27

The FDA (Devices) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2018-06-27
Critical
4
Units
202

Why these products were recalled

The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC module would not prevent setting an N2O flow that would result in a hypoxic mixture from being dosed to the patient. Potential adverse outcomes include death of the patient.

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

1–5 of 5

  • CriticalFDA (Devices)··2018-06-27

    Draeger Apollo Anesthesia Machine Recalled for Potential Hypoxic Gas Delivery

    Draeger Medical is recalling 72 Apollo Anesthesia Machines because a fault could allow the device to deliver a hypoxic gas mixture to patients, posing a risk of death.

    Product
    Apollo Anesthesia Machine; Cat. no. 8605310 Product Usage: Indicated as a continuous flow anesthesia system. The Apollo may be used for manually assisted or automatic ventilation, delivery of gases and anesthetic vapor, and monitoring of oxygen and CO2 concentration, breathin
    Category
    Distribution
    33 states
  • CriticalFDA (Devices)··2018-06-27

    Draeger Fabius GS Premium Anesthesia Machine Recalled for Hypoxia Risk

    Draeger Medical is recalling 62 Fabius GS Premium Anesthesia Machines because a fault could allow the device to deliver a hypoxic gas mixture to patients.

    Product
    Fabius GS Premium Anesthesia Machine; Cat. no. 8607000 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fa
    Category
    Distribution
    33 states
  • CriticalFDA (Devices)··2018-06-27

    Draeger Fabius GS MRI Anesthesia Machine Recalled for Hypoxia Risk

    Draeger Medical is recalling four Fabius GS MRI Anesthesia Machines because a fault could allow the device to deliver a hypoxic gas mixture to patients, potentially causing death.

    Product
    Fabius GS MRI Anesthesia Machine; Cat. no. 8607300 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius
    Category
    Distribution
    33 states
  • SevereFDA (Devices)··2018-06-27

    Draeger Perseus A500 Anesthesia Machine Recalled for Hypoxic Mixture Risk

    Draeger Medical is recalling 33 Perseus A500 anesthesia machines because a fault could allow the device to deliver a hypoxic gas mixture to patients.

    Product
    Perseus A500 Anesthesia Machine; Cat. no. MK06000 Product V Product Usage: Intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressuresupported spontaneous breathing, and spontaneous breathing. Perseus is
    Category
    Distribution
    33 states
  • CriticalFDA (Devices)··2018-06-27

    Draeger Fabius GS Tiro Anesthesia Machine Recalled for Hypoxia Risk

    Draeger Medical is recalling 31 Fabius GS Tiro anesthesia machines because a fault could allow 100% nitrous oxide delivery, creating a risk of hypoxic mixtures and patient death.

    Product
    Fabius GS Tiro Anesthesia Machine; Cat. no. 8606000 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabiu
    Category
    Distribution
    33 states