The Recall Desk

FDA (Devices) recall action 72914

Draeger Medical, Inc. recalled 2 products on 2016-02-10

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2016-02-10
Critical
0
Units
—

Why these products were recalled

Drager became aware of situations where the error message "Poti unplugged" was generated causing acoustic and visual alarms, the breathing system releases pressure and the ventilation function stops operating.

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

States named across these recalls

1–2 of 2

  • SevereFDA (Devices)··2016-02-10

    Draeger Oxylog 2000 Plus Ventilator Recalled for Malfunction

    Draeger Medical is recalling Oxylog 2000 Plus ventilators because a software error can stop ventilation and trigger alarms.

    Product
    Emergency Transport Ventilator Oxylog 2000 Plus Ventilator Catalog Number: 5705080. Volume controlled emergency and transport ventilator with pressure support.
    Category
    Distribution
    39 states
  • SevereFDA (Devices)··2016-02-10

    Draeger Oxylog 3000 Ventilators Recalled for Software Error

    Draeger Medical is recalling Oxylog 3000 and Oxylog 3000 Plus ventilators because a software error can stop ventilation and trigger alarms.

    Product
    Emergency Transport Ventilator Oxylog 3000 Ventilator and Oxylog 3000 plus Ventilator Catalog Numbers: 2M86300/2M86965 and 5704813/5704831. Volume controlled and pressure-controlled emergency and transport ventilators.
    Category
    Distribution
    39 states