CLASS II Device recall · Reported 19 Apr 2017 · FDA Enforcement Report

Delta XL recalled by Draegar Medical Systems

Draegar Medical Systems is recalling Delta XL, distributed nationwide in the US. The recall was initiated on 28 Mar 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesVF10.0 software

Quantity recalled2,156 (total for all devices)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1773-2017
FDA event ID: 76862
Recalling firm: Draegar Medical Systems, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 28 Mar 2017
FDA classified: 10 Apr 2017
Reported: 19 Apr 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Patient Monitors

Timeline

28 Mar 2017	Recall initiated by company
10 Apr 2017	Classified by FDA	+13 days
19 Apr 2017	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide Alabama Arkansas California Colorado Georgia Illinois Louisiana Massachusetts New York Ohio Pennsylvania Tennessee Texas Virginia

Questions about this recall

Is Delta XL recalled?

Yes. Draegar Medical Systems recalled Delta XL on 28 Mar 2017. The recall is Class II and its status is Terminated. Recall number Z-1773-2017.

Why was it recalled?

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

Which lots are affected?

VF10.0 software

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Draegar Medical Systems

All 13

Reported	Class	Recall	Company	Reason	Where
4 May 2022Device	CLASS II	Drager Infinity CentralStation recalled by Draegar Medical Systems	Draegar Medical Systems	Device Malfunction	Nationwide
17 Feb 2021Device	CLASS II	Infinity Acute Care System (Iacs) Monitoring Solution recalled	Draegar Medical Systems	Other	Nationwide
20 Nov 2019Device	CLASS II	Infinity M300 telemetry monitoring device recalled	Draegar Medical Systems	Device Malfunction	Nationwide
6 Nov 2019Device	CLASS II	The Infinity Acute Care System recalled by Draegar Medical Systems	Draegar Medical Systems	Device Malfunction	Nationwide
13 Mar 2019Device	CLASS II	Omega Systems These devices are intended to be used recalled	Draegar Medical Systems	Device Malfunction	Nationwide

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9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
2 Sep 2026Device	CLASS II	IQecg Digital ECG recalled by Midmark	Midmark	Labeling Errors	Nationwide