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Draeger Medical Systems, Inc.

United States·US-MF-000020721

Last updated September 17, 2026

Information

Country: United States
Address: 3135, Quarry Road, Telford, PA, United States
Website: www.Draeger.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +19784473613
PRRC Contact: Karl Nittinger
EUDAMED SRN: US-MF-000020721
FDA FEI Number: 3005783425
DUNS Number: —

Catalogue (350)

Page 1 of 7

Device	Model / Reference	Registries	Class	Status
Hzv-Thermistorkabel Für Picco	MS16919	EUDAMED	Class I	Active
Ekg Neo Adapter-Pin, 10 Stk.	5194779	EUDAMED	Class I	Active
Kbl Alarmausg, Intf-Platte, 5m	4314626	EUDAMED	Class I	Active
Probe 5, Skin Temp, Reusable	MU12533	EUDAMED	Class IIb	Active
Hemomed-Kabel Zu Monitor 3m	5591925	EUDAMED	Class I	Active
Temp.Probe Cover, gr., Box/100	MU06943	EUDAMED	Class I	Active
Prüfkopf 1, Hauttemperatur 10	MU06933	EUDAMED	Class IIb	Active
Shp Acc Cable Y X8-X8	MS24539	EUDAMED	Class I	Active
Hauttemp.-Sensor3, Dual, EW, BX10	MU11228	EUDAMED	Class IIb	Active
Kabel Masimo RD-SET, 1.2m	MS34436	EUDAMED	Class I	Active
Infinity Picco Smartpod Gen2	MS23133	EUDAMED	Class IIb	Active
Kabel Scio/M540 2.2m	MS33167	EUDAMED	Class I	Active
Pod-Kommunikationskabel 3m	3368425	EUDAMED	Class I	Active
Pod-Kommunikationskabel 0, 3m	7257988	EUDAMED	Class I	Active
Temp.sonde, Abdeckung, Box/100	MU06944	EUDAMED	Class I	Active
Probe, Skin Temp, Centrl, Bx10	MU26041	EUDAMED	Class IIb	Active
SUCTION BOTTL, 800mL, DISP, BOX20	MU10918	EUDAMED	Class IIb	Active
Adapter Db9f-Rj45	MS32958	EUDAMED	Class I	Active
Adapterkabel Picco Zu 10-Polig	MS16920	EUDAMED	Class I	Active
4 Adr Ekg Verlaengerungskbl 2m	MS31435	EUDAMED	Class I	Active
Shp Unt Infinity M540 V2	MS41200	EUDAMED	Class IIb	Active
NIBP-Schlauch, neonat. Manschetten, 2, 4 m	2870298	EUDAMED	Class I	Active
Pod-Kommunikationskabel 5m	5195198	EUDAMED	Class I	Active
Probe 3, Skin Temp, Reusable	MU11225	EUDAMED	Class IIb	Active
Kabel Scio/M540 0.8m	MS33168	EUDAMED	Class I	Active
Hauttemp.-Sensor5, gr ., BX10	MU12551	EUDAMED	Class IIb	Active
Shp Unit Infinity CNAP Pod	MS16905	EUDAMEDFDA UDI	Class II	Active
MonoLead 5, Dual Pin, Euro, 2.5M	MS16161	FDA UDI	Class II	Active
Cardiac Output Kit Baxter	7265155	FDA UDI	Class II	Active
Ventilator tubing support kit	MU18660	FDA UDI	Class I	Active
etCO2 PodKit w/Holder+Sensor	MS29408	FDA UDI	Class II	Active
SpO2 Draeger Neo Band, 24 pcs.	MS16446	FDA UDI	Class II	Active
etCO2 S-Cannula - Adult	4714395	FDA UDI	Class II	Active
Infinity Cnap Smartpod	MS17075	FDA UDI	Class II	Active
Hemo Pod Adapter, Abbott/Medex	5196998	EUDAMEDFDA UDI	Class II	Active
SpO2 Nellcor Interm Cable, 1M	3368433	EUDAMEDFDA UDI	Class II	Active
SpO2 MasimoSET Pod Set - Kappa XLT	MS16903	FDA UDI	Class II	Active
ECG Cbl MonoLead 4 AHA/US 1.7m	MS14694	EUDAMEDFDA UDI	Class II	Active
Block F. Eeg Ref Id Conversion	5954859	FDA UDI	Class II	Active
Delta Monitor	MS18597	FDA UDI	Class II	Active
etCO2 Respiratory Mechanics Pod	5740704	FDA UDI	Class II	Active
Innovian CC	MS20026	FDA UDI	Class I	Unknown
Ecg 6-Lead Single-Pin Euro, 1m	MS16157	FDA UDI	Class II	Active
NIBP Neo #5 Cuff 8.3 - 15 cm	2870173	FDA UDI	Class II	Unknown
Transducer Cable, Argon	MS22148	EUDAMEDFDA UDI	Class II	Active
Infinity Masimo Spo2 Pod X8	MS16356	EUDAMEDFDA UDI	Class II	Active
Shp Unt Infinity Central Station	MS18384	FDA UDI	Class II	Active
S/W Sub Vf7.1 Gateway	MS33373	FDA UDI	Class II	Active
Infinity Mcable-Rainbow Set	MS27003	FDA UDI	Class II	Active
ECG ESU block, 5-lead	5947226	FDA UDI	Class II	Active

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FDA Recalls (21)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jan 14, 2025	Z-1066-2025	—	open, classified	Edifier speakers (shipped in or after April 2023) may not annunciate when configured in analog mode which can lead to delayed treatment to the patient.
May 13, 2024	Z-2189-2024	—	open, classified	Device is not in full compliance to Type CF requirements of IEC 60601-1 and IEC 60601-2-34 standards. Therefore, there is a potential risk of electric shock. Health consequences may include electrical shock, burns, and cardiac arrhythmia.
May 16, 2023	Z-1992-2023	—	open, classified	The Resuscitaire Infant Radiant Warmer with the optional scale could display inaccurate weight values.
Apr 5, 2023	Z-1472-2023	—	open, classified	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.
Apr 5, 2023	Z-1471-2023	—	open, classified	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.
May 20, 2022	Z-1365-2022	—	open, classified	The firm has initiated this recall to replace component on devices distributed containing a component within the oxygen supply system that is not rated to the working pressure of the system.
May 15, 2018	Z-2046-2018	—	terminated	Users have misinterpreted the display for out of range measurement indicated by the blinking" ---" to mean a zero measurement.
May 15, 2018	Z-2047-2018	—	terminated	Users have misinterpreted the display for out of range measurement indicated by the blinking "-0-" to mean a zero measurement
Mar 5, 2014	Z-1440-2014	—	terminated	The potentiometers (knobs) for setting the ventilation parameters may have contact interrupted and the device discontinues ventilation, gives an audible alarm and displays the error message Poti unplugged.
Feb 7, 2014	Z-1298-2014	—	terminated	The battery capacity of the optional PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected.
Dec 10, 2013	Z-0714-2014	—	terminated	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.
Jul 2, 2012	Z-1950-2012	—	terminated	A routine internal quality check found that the Drager PT 4000 Phototherapy System is fitted with a 16 Amp rated fuse instead of the specified 1.6 Amp rated fuse. This may mean that the internal fuse would not trip promptly in the event of an internal short-circuit. The possible consequence is the wall outlet circuit breaker would trip first on the device may severely overheat. There have not b
Jul 29, 2011	Z-3047-2011	—	terminated	Monitor keys may spontaneously become inoperative or active. This may cause a membrane switch panel malfunction, which could result in the monitor discharging a patient automatically.
Jul 29, 2011	Z-3048-2011	—	terminated	Monitor keys may spontaneously become inoperative or active. This may cause a membrane switch panel malfunction, which could result in the monitor discharging a patient automatically.
Aug 26, 2010	Z-2479-2010	—	terminated	potential failures to Electri-Cord Manufacturing AC power cord
Aug 26, 2010	Z-2478-2010	—	terminated	potential failures to Electri-Cord Manufacturing AC power cord
Aug 19, 2010	Z-0018-2011	—	terminated	Patients received insufficient ventilation. The Oxylog 3000 Instructions are inadequate relating to dead space volume.
Jun 4, 2010	Z-2283-2010	—	terminated	Monitor keys may become inoperative or activate spontaneously, causing a membrane switch panel malfunction. This may discharge a patient automatically.
Jun 4, 2010	Z-2284-2010	—	terminated	Monitor keys may become inoperative or activate spontaneously, causing a membrane switch panel malfunction. This may discharge a patient automatically.
Jul 29, 2009	Z-1693-2009	—	terminated	Spark, flame and smoke: A mis-positioned crimp on heater element lead wire resulted in flame and smoke aerating from the top of the warmer assembly.
Jul 17, 2009	Z-1955-2009	—	terminated	Hot particles fell into the infant bassinet beneath a Radiant Infant Warmer. The resulting fire injured an infant. These devices are obsolete.