Recall Z-0974-2019— Draegar Medical Systems, Inc.

Name: FDA recall Z-0974-2019
Creator: U.S. Food and Drug Administration
Published: 2019-02-08

Class II · Ongoing

Class II FDA medical device recall by Draegar Medical Systems, Inc., initiated 2019-02-08. It names one FDA 510(k) clearance: K152407. 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 for use in the adult and pediatric populations only; and tcp02, which for the neonatal population, is to only be used when the patient is not under gas anesthesia.-Omega and Omega S are intended to be used on adult, pediatric, and neonatal populations.. Reason: 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..

Recalling firm: Draegar Medical Systems, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2019-02-08
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K152407 — Infinity Delta, Infinity Delta XL, Infinity KappaDraeger Medical Sytems, Inc.·cleared 2015-09-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 for use in the adult and pediatric populations only; and tcp02, which for the neonatal population, is to only be used when the patient is not under gas anesthesia.-Omega and Omega S are intended to be used on adult, pediatric, and neonatal populations.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.