The Recall Desk

FDA (Devices) recall action 82014

Draegar Medical Systems, Inc. recalled 2 products on 2019-03-13

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
2019-03-13
Critical
0
Units
21,398

Why these products were recalled

The firm is recalling their Delta family of patient monitors software due to cybersecurity vulnerabilities, which may cause the device to reboot, lose functionality, and/or lose communication.

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

1–2 of 2

  • HighFDA (Devices)··2019-03-13

    Draegar Medical Systems Recalls Omega Patient Monitor Software

    Draegar Medical Systems is recalling Omega patient monitor software due to cybersecurity vulnerabilities that may cause device reboots or loss of functionality.

    Product
    Omega Systems These devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2019-03-13

    Draeger Infinity Delta Patient Monitors Recalled for Cybersecurity Vulnerabilities

    Draeger Medical Systems is recalling Infinity Delta patient monitors due to cybersecurity vulnerabilities that may cause device reboots or loss of functionality.

    Product
    Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended fo
    Category
    Distribution
    1 state