CLASS II Device recall · Reported 25 Apr 2018 · FDA Enforcement Report

Infinity Acute Care System (IACS) Monitoring Solution recalled

Draegar Medical Systems is recalling Infinity Acute Care System (IACS) Monitoring Solution, distributed nationwide in the US. The recall was initiated on 21 Feb 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog Number(s): MS18841, MS20401, MS20407, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751

Quantity recalled28317 total products

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-1382-2018
FDA event ID: 79648
Recalling firm: Draegar Medical Systems, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 21 Feb 2018
FDA classified: 16 Apr 2018
Reported: 25 Apr 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Patient Monitors

Timeline

21 Feb 2018	Recall initiated by company
16 Apr 2018	Classified by FDA	+54 days
25 Apr 2018	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

The invasive pressure visual and audible alarms may not activate.

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

Infinity Acute Care System (IACS) Monitoring Solution, Catalog Numbers: MS18841, MS20401, MS20407, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751 Multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by trained healthcare professsionals. The lACS obtains the physiologic, multi-parameter data from the connection to the M540 monitor and optional medical devices and displays. The transfer of this data is accomplished by the Infinity network. The M540 is intended to monitor one patient at a time.

Where it was distributed

Worldwide Distribution - USA (nationwide) and the following countries:Angola, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bolivia, Botswana, Brazil, Brunei Dar-es-S, Bulgaria, Canada, Chile, China, Columbia, Costa Rica, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Liechtenstein, Lithuania, Macedonia, Malaysia, Maldives, Mexico, Monaco, Mozambique, Namibia, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Poland, Portugal, Qatar, Reunion, Russian Fed., Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Trinidad and Tobago, Turkey, Turkmenistan, United Kingdom, Utd.Arab.Emir. and Vietnam.

Nationwide

Questions about this recall

Is Infinity Acute Care System (IACS) Monitoring Solution recalled?

Yes. Draegar Medical Systems recalled Infinity Acute Care System (IACS) Monitoring Solution on 21 Feb 2018. The recall is Class II and its status is Terminated. Recall number Z-1382-2018.

Why was it recalled?

The invasive pressure visual and audible alarms may not activate.

Which lots are affected?

Catalog Number(s): MS18841, MS20401, MS20407, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751

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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