Device recall: Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the…

Class II FDA enforcement event 91938. Recall start date: 5 Apr 2023. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity M300 to fail to meet Frequency and Impulse Response requirements. In this condition, ECG waveforms with unusually narrow and/or high frequency QRS may be displayed or printed with QRS amplitudes intermittently lower than actual.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Draeger Medical Systems, Inc. started this device recall on 5 Apr 2023. The firm address in the FDA record is in Andover, MA. FDA put the recall in Class II. FDA event 91938 has 2 product records. The first FDA enforcement report date is 3 May 2023. The record gives the status Ongoing.

FDA enforcement report The 2 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide - US Nationwide distribution.

Recalling firm

Draeger Medical Systems, Inc., Andover, MA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

2 product records in the event.

FDA event 91938: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1471-2023	Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment, Software versions VG2.1.3 and lower	6803 systems	Class II	Ongoing	3 May 2023
Z-1472-2023	Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory adult and pediatric patients using wireless communication over the Infinity patient monitoring network,	19,429 systems	Class II	Ongoing	3 May 2023

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2023: 917
Share of these events in Class II: 88%
Product records in this event: 2Median of the firm: 1
Events of the firm on the register: 10

Other events of the firm

Other FDA enforcement events of Draeger Medical Systems, Inc.
Initiated	Product (first record)	Type	Class	Records
14 Jan 2025	Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized monitoring	Device	Class II	1
13 May 2024	Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23	Device	Class II	1
16 May 2023	Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s): RW82VHA-1, RW82VHA-1C, RW82VHA-1D, RW82-1	Device	Class II	1
20 May 2022	Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal transport system	Device	Class II	1
15 May 2018	Draeger Jaundice Meter JM-103 The device is intended for use in hospitals, clinics or doctor s offices under a physician	Device	Class I	2
5 Mar 2014	Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833	Device	Class I	1
7 Feb 2014	Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500), Evita V500 and /or	Device	Class I	1
10 Dec 2013	Draeger Infinity Acute Care System Monitoring Solution	Device	Class II	1
2 Jul 2012	Drager PT 4000 Phototherapy System	Device	Class II	1

Draeger Medical Systems, Inc.: all 10 events

Official channels

FDA enforcement report Z-1471-2023The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 91938. https://recallregister.com/fda/ii/91938/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide - US Nationwide distribution.
What quantity of product is in FDA event 91938?: The event has 2 product records. The first record gives this quantity: 6803 systems
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2023 have the same class?: 88% of the 917 device events that started in 2023 are in Class II.