The Recall Desk

FDA (Devices) recall action 79773

Draeger Medical, Inc. recalled 4 products on 2018-05-16

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
2018-05-16
Critical
0
Units
62

Why these products were recalled

The automatic ventilation may fail if the position detection of the motor is disturbed. If the ventilator cover is damaged, manual ventilation may also fail.

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)··2018-05-16

    Draeger Fabius MRI Anesthesia Machines Recalled for Ventilation Failure Risk

    Draeger Medical is recalling eight Fabius MRI anesthesia machines because automatic or manual ventilation may fail if the motor position is disturbed or the ventilator cover is damaged.

    Product
    Fabius MRI, anesthesia machine, catalog no. 8607300 Product Usage: The products are 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
    Category
    Distribution
    21 states
  • SevereFDA (Devices)··2018-05-16

    Draeger Fabius GS Premium Anesthesia Machines Recalled for Ventilation Failure Risk

    Draeger Medical is recalling 27 Fabius GS Premium anesthesia machines because automatic ventilation may fail if motor position detection is disturbed.

    Product
    Fabius GS Premium, anesthesia machine, catalog no. 8607000 Product Usage: The products are 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 moun
    Category
    Distribution
    21 states
  • SevereFDA (Devices)··2018-05-16

    Draeger Fabius Tiro Anesthesia Machines Recalled for Ventilation Failure Risk

    Draeger Medical is recalling 26 Fabius Tiro anesthesia machines because automatic ventilation may fail if motor position detection is disturbed.

    Product
    Fabius Tiro, anesthesia machine, catalog no. 8606000 Product Usage: The products are 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 ga
    Category
    Distribution
    21 states
  • SevereFDA (Devices)··2018-05-16

    Draeger Fabius Tiro M Anesthesia Machine Recalled for Ventilator Failure Risk

    Draeger Medical is recalling one Fabius Tiro M anesthesia machine because automatic ventilation may fail if motor position detection is disturbed.

    Product
    Fabius Tiro M, anesthesia machine, catalog no. 8608400 Product Usage: The products are 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
    Category
    Distribution
    21 states