Draegar Medical Systems, Inc.: It was reported that a set low O2 alarm does not go off although the measured O2 level is below the alarm limit.

Agency Publication Date: April 10, 2017

Affected Products

Product: Delta, Catalog Number: MS18597 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus. Product Usage: The 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 patients medical condition. The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended

VF10.0 software

Product: Delta XL, Catalog Number: MS18596 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus. Product Usage: The 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 patients medical condition. The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intende

VF10.0 software

Product: Kappa, Catalog Number: MS18853 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus. Catalog Number(s): MS18597/MS18596/MS18853. Product Usage: The 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 patients medical condition. The Infinity Delta Series (

VF10.0 software

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 76862

Status: Resolved

Manufacturer: Draegar Medical Systems, Inc.

Manufactured In: United States

Units Affected: 3 products (2,156 (total for all devices))

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Sources: FDA iRES · Raw API Response

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Affected Products

VF10.0 software