Z-1772-2017Class II

Delta, Catalog Number: MS18597 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio...

Name: Z-1772-2017 Delta, Catalog Number: MS18597 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio...
Creator: Draegar Medical Systems, Inc.
Published: 2017-03-28
License: https://open.fda.gov/license/

Draeger Medical Systems, Inc. / initiated 2017-03-28 / Terminated

FDA source

Draegar Medical Systems, Inc. began a recall of 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... on 2017-03-28. FDA classified it as Class II and gives the reason as "It was reported that a set low O2 alarm does not go off although the measured O2 level is below the alarm limit". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1772-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-28
Posted: 2017-04-10
Terminated: 2018-09-17
Recalling firm: Draeger Medical Systems, Inc.
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 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.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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.
FDA root cause: Under Investigation by firm
Action: On March 28, 2017, US consignees were sent an Urgent Medical Recall letter and Customer Reply and Order card. Delta family monitors running software version 10.0 in facilities that also have at least one Scio module will be downgraded to software version VF9.1 as a temporary solution Free of Charge. Draeger Medical Systems, Inc. is developing a new software version to resolve the issue (VF10.1). Once available, all Delta family monitors that were running software version VF10.0 will be upgraded with VF10.1 Free of Charge. For all other countries, the responsible local Draeger Sales and Service will mail the letter and card.
Quantity in commerce: 2,156 (total for all devices)
Distribution: Worldwide - US Nationwide distribution in the states of: AL, CA, GA, IL, LA, MA NY, OH, PA, TN, TX and VA and the countries of: AR AT BE BG BN BO BY CA CH CL CO CZ DE EG ES FI FR GB GR HR HU ID IE IL IN IT LT MX MY NL NO NP PA PE PK PL PT RO RS RU SA SE SK TH TR TW UG UZ VN ZA
Product codes and lots: VF10.0 software

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1772-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1772-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-10
Z-1773-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-10
Z-1774-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-10

Product code MHX

K152407Class IIInfinity Delta, Infinity Delta XL, Infinity KappaDraeger Medical Sytems, Inc. / cleared 2015-09-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)