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GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

United States·US-MF-000017529

Last updated September 17, 2026

Information

Country: United States
Address: 3114, N Grandview Blvd, Waukesha, United States
Website: gehealthcare.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)558-7044
PRRC Contact: Kimberly Mangum
EUDAMED SRN: US-MF-000017529
FDA FEI Number: 3012359877
DUNS Number: 784985108

Catalogue (666)

Page 1 of 14

Device	Model / Reference	Registries	Class	Status
CARESCAPE Gateway	5697315-002	EUDAMED	Class I	Active
Classic-Cuf	CLA-P1-2A	FDA UDI	Class II	Active
Soft-Cuf	2117	FDA UDI	Class II	Unknown
Classic-Cuf	CLA-T1-2A-X	FDA UDI	Class II	Unknown
GE Client Software	A1	FDA UDI	Class II	Unknown
Dura-Cuf	002772	FDA UDI	Class II	Unknown
Classic-Cuf	2670	FDA UDI	Class II	Unknown
Classic-Cuf	2119	FDA UDI	Class II	Active
Sensa-Cuf	2480	FDA UDI	Class II	Unknown
Dura-Cuf	DUR-A2-2A	FDA UDI	Class II	Active
Classic-Cuf	2603	FDA UDI	Class II	Unknown
Soft-Cuf	2502-INT	FDA UDI	Class II	Unknown
Soft-Cuf	002331	FDA UDI	Class II	Unknown
My-Cuf	MY-A2-2A	FDA UDI	Class II	Unknown
One-Cuf	ONE-A2-2A-L	FDA UDI	Class II	Unknown
Soft-Cuf	2403	FDA UDI	Class II	Unknown
One-Cuf	ONE-P1-2A	FDA UDI	Class II	Unknown
Classic-Cuf	2633	FDA UDI	Class II	Active
MLCL Upgrade	AltiX	FDA UDI	Class II	Active
Classic-Cuf	2673	FDA UDI	Class II	Unknown
Dura-Cuf	002757	FDA UDI	Class II	Unknown
Sensa-Cuf	2486	FDA UDI	Class II	Unknown
Soft-Cuf	SFT-A1-2A	FDA UDI	Class II	Active
Soft-Cuf	002332	FDA UDI	Class II	Unknown
My-Cuf	MY-A3-2A	FDA UDI	Class II	Unknown
My-Cuf	MY-A1-2A	FDA UDI	Class II	Unknown
Soft-Cuf	2322	FDA UDI	Class II	Unknown
Dura-Cuf	DUR-P2-2A	FDA UDI	Class II	Active
Mural Clinical Viewer	1.3	FDA UDI	Class II	Active
Cam-Usb	INTERFACE V2	FDA UDI	Class II	Active
Soft-Cuf	2122	FDA UDI	Class II	Active
Mac	5500 HD	FDA UDI	Class II	Active
Carescape	Telemetry Server V4	FDA UDI	Class II	Active
Sensa-Cuf	SEN-T1-2A	FDA UDI	Class II	Unknown
Soft-Cuf	2116	FDA UDI	Class II	Unknown
Dura-Cuf	002784	FDA UDI	Class II	Unknown
Classic-Cuf	2356	FDA UDI	Class II	Unknown
Soft-Cuf	2505	FDA UDI	Class II	Unknown
Sensa-Cuf	2460	FDA UDI	Class II	Unknown
Dura-Cuf	002767	FDA UDI	Class II	Unknown
Mac	2000	FDA UDI	Class II	Unknown
Dura-Cuf	002202	FDA UDI	Class II	Unknown
My-Cuf	MY-T1-1B	FDA UDI	Class II	Unknown
Classic-Cuf	2652	FDA UDI	Class II	Unknown
My-Cuf	MY-T1-2E	FDA UDI	Class II	Unknown
Sensa-Cuf	2474	FDA UDI	Class II	Unknown
Dura-Cuf	002771	FDA UDI	Class II	Unknown
Classic-Cuf	2128	FDA UDI	Class II	Active
My-Cuf	MY-A2-2C	FDA UDI	Class II	Unknown
My-Cuf	MY-A3-2C	FDA UDI	Class II	Unknown

Related Companies

Authorised Representatives

GE Medical Systems SCS FR

Importers

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Authorities

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FDA Recalls (22)

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
Apr 24, 2026	Z-2243-2026	—	open, classified	GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).
Apr 24, 2026	Z-2244-2026	—	open, classified	GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).
Apr 24, 2026	Z-2245-2026	—	open, classified	GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).
Apr 24, 2026	Z-2247-2026	—	open, classified	GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).
Apr 24, 2026	Z-2246-2026	—	open, classified	GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).
Apr 24, 2026	Z-2242-2026	—	open, classified	GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).
Apr 24, 2026	Z-2279-2026	—	open, classified	Electrical sparking may occur at the printer head. If the Electrostatic Discharge (ESD) printer brush becomes dislodged, electrical sparking at the printer head can result in charring or discoloration of thermal printer paper. Ignition of the paper could potentially result in serious thermal injury.
Apr 25, 2025	Z-1938-2025	—	open, classified	The MUSE Administrator Account active directory or local credential could potentially be used from your local network to log into a GE HealthCare MUSE 5 system and potentially manipulate recorded patient data.
Apr 22, 2024	Z-2258-2024	—	open, classified	Capacitors in certain Prucka 3 Amplifiers used with CardioLab / ComboLab systems could fail resulting in transient oscillations on the display and inability to view surface and intracardiac ECG waveforms.
Apr 9, 2024	Z-2027-2024	—	open, classified	Use of the blood pressure cuffs could result in inaccurate non-invasive blood pressure measurements.
Aug 8, 2023	Z-2613-2023	—	open, classified	A diode on the power supply of the Prucka 3 Amplifier used with CardioLab/ComboLab systems could reach elevated temperatures and fail, then power off and become inoperable.
Jan 11, 2018	Z-0487-2018	—	terminated	CARESCAPE Central Station (CSCS) software version 2.0.2 units may experience unexpected NO COMM (No Communication) and network communication issues after boot-up or system restart.
Jul 13, 2017	Z-0202-2018	—	terminated	Device does not produce a visual or audible impedance respiration APN alarm when an impedance respiration apnea event occurs.
Jul 18, 2005	Z-1421-05	—	terminated	The potential exists for the AI1000 workstation to mix images from one study with images from another study. Mixed studies could be from the same patient or from different patients. Mixed patient images could compromise patient condition or diagnosis and treatment.
Jan 27, 2004	Z-1015-04	—	terminated	The potential exists for external electrical noise to be processed as irregular pacing thereby masking potential asystole events.
May 21, 2003	Z-1291-03	—	terminated	The 2120 Main Board on device lacks required external safety 'watchdog' circuit.
Apr 30, 2003	Z-0011-04	—	terminated	Reports of broken plug ground pins on AC power cords for patient monitors.
Mar 7, 2001	Z-1237-03	—	terminated	Wrong connector attached to blood pressure cuff.
Nov 16, 2000	Z-0014-04	—	terminated	Instructions for use contained incorrect sensor reference.
Nov 16, 2000	Z-0015-04	—	terminated	Instructions for use contained incorrect sensor reference.
Nov 16, 2000	Z-0013-04	—	terminated	Instructions for use contained incorrect sensor reference.
Oct 24, 2000	Z-1236-03	—	terminated	Incorrrect male connector attached to tubing preventing the correct connection of blood pressure cuff.