Recall Z-1773-2017— Draegar Medical Systems, Inc.

Name: FDA recall Z-1773-2017
Creator: U.S. Food and Drug Administration
Published: 2017-03-28

Class II · Terminated

Class II FDA medical device recall by Draegar Medical Systems, Inc., initiated 2017-03-28, terminated 2018-09-17. It names one FDA 510(k) clearance: K152407. 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 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 tcpO2, which for the neonatal population, is to only be used when the patient is not under gas anesthesia. For combination with Scio gas module: Scio gas module samples breathing gases from adults and pediatrics. The gas module continuously measure the content of CO2, N2O, O2 and one of the anesthetic agents, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane in any mixture and communicates real time and derived gas information to the In-finity monitors.. Reason: It was reported that a set low O2 alarm does not go off although the measured O2 level is below the alarm limit..

Recalling firm: Draegar Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-03-28
Terminated: 2018-09-17
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

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 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 tcpO2, which for the neonatal population, is to only be used when the patient is not under gas anesthesia. For combination with Scio gas module: Scio gas module samples breathing gases from adults and pediatrics. The gas module continuously measure the content of CO2, N2O, O2 and one of the anesthetic agents, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane in any mixture and communicates real time and derived gas information to the In-finity monitors.

Reason for recall

It was reported that a set low O2 alarm does not go off although the measured O2 level is below the alarm limit.

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