The Recall Desk

FDA (Devices) recall action 95561

Draeger Medical, Inc. recalled 2 products on 2024-11-20

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
2024-11-20
Critical
1
Units
—

Why these products were recalled

The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

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

States named across these recalls

1–2 of 2

  • SevereFDA (Devices)··2024-11-20

    Anesthesia workstation piston ventilator may fail before or during use

    Draeger Medical is recalling Atlan A350XL anesthesia workstations due to potential piston ventilator failure that may occur before use or during mechanical ventilation.

    Product
    Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Component: Not applicable
    Category
    Distribution
    21 states
  • CriticalFDA (Devices)··2024-11-20

    Draeger Atlan A350 Anesthesia Workstation Piston Ventilator Failure

    Draeger Medical is recalling the Atlan A350 anesthesia workstation due to failures of the piston ventilator that either occurred before use or during patient anesthesia. Approximately 1,492 units are affected.

    Product
    Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable
    Category
    Distribution
    21 states