CLASS II Device recall · Reported 22 Jan 2014 · FDA Enforcement Report

Draeger Infinity Acute Care System Monitoring Solution recalled

Draeger Medical Systems is recalling Draeger Infinity Acute Care System Monitoring Solution, distributed in 8 states. The recall was initiated on 10 Dec 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codeswith software versions VG2.0.3 and higher.

Quantity recalled439

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-0714-2014
FDA event ID: 67056
Recalling firm: Draeger Medical Systems, Telford, PA
Classification: Class II
Status: Terminated
Recall initiated: 10 Dec 2013
FDA classified: 10 Jan 2014
Reported: 22 Jan 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Patient Monitors

Timeline

10 Dec 2013	Recall initiated by company
10 Jan 2014	Classified by FDA	+31 days
22 Jan 2014	Published in enforcement report	+12 days

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

Reason for recall

After a test in which a low SpO2 (yellow) medium grade alarm initiated in neo-natal mode and was subsequently paused, the high grade life threatening SpO2 alarm (red) did not activate when the SpO2 values were decreased to reach the red 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

Draeger Infinity Acute Care System Monitoring Solution

Where it was distributed

US Distribution including the states of: MA, NH, IN, CA, TX, NY, OK, and IL.

California Illinois Indiana Massachusetts New Hampshire New York Oklahoma Texas

Questions about this recall

Why was it recalled?

Which lots are affected?

with software versions VG2.0.3 and higher.

Where was it sold?

US Distribution including the states of: MA, NH, IN, CA, TX, NY, OK, and IL.

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 26 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 Draeger Medical Systems

All 12

Reported	Class	Recall	Company	Reason	Where
5 Feb 2025Device	CLASS II	Infinity Central Station recalled by Draeger Medical Systems	Draeger Medical Systems	Device Malfunction	Nationwide
3 Jul 2024Device	CLASS II	Infinity Acute Care System (IACS) Monitoring System recalled	Draeger Medical Systems	Other	Nationwide
28 Jun 2023Device	CLASS II	Draeger Softbed Resuscitaire and/or Birthing Room Warmer recalled	Draeger Medical Systems	Labeling Errors	Nationwide
3 May 2023Device	CLASS II	Draeger Infinity CentralStation (ICS) recalled	Draeger Medical Systems	Device Malfunction	Nationwide
3 May 2023Device	CLASS II	Draeger Infinity M300 and M300+, for use recalled	Draeger 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