Ge Medical Systems Information Technologies, Inc.
Ge Medical Systems Information Technologies, Inc. holds FDA 510(k) medical device clearances, first cleared 2010, most recent 2026, with 19 FDA device recalls on record.
Top product codes for Ge Medical Systems Information Technologies, Inc.
FDA recalls by Ge Medical Systems Information Technologies, Inc.
10 most recent of 19- Z-3038-2026 — PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353
- Z-3037-2026 — PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592
- Z-3039-2026 — FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225
- Z-3036-2026 — PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209
- Z-2878-2026 — GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring system
- Z-2876-2026 — GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph
- Z-2246-2026 — GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Z-2247-2026 — GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Z-2245-2026 — GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Z-2279-2026 — CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Ge Medical Systems Information Technologies, Inc.
- K253277 — Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P
- K251670 — MAC 7 Resting ECG Analysis System
- K242562 — Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P
- K243540 — Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)
- K233810 — Portrait VSM
- K234130 — Portrait Mobile Monitoring Solution consists of: Portrait Central Viewer Application (Portrait CVAXB) Portrait Core Services (Portrait CSSXB) Portrait Clinical Alarming Unit (Portrait CAU01) Portrait Mobile Patient Monitor Hardware (Portrait HUBXB) Portrait Mobile Patient Monitor Software (Portrait HSWXB) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) Portrait Wearable Pulse O
- K231870 — CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System
- K230626 — Portrait Central Viewer Application (Portrait CV A01), Portrait Core Services (Portrait CSS01), Portrait Clinical Alarming Unit (Portrait CAU01) +3 more
- K230145 — ONE-CUF
- K222586 — Mural Clinical Viewer
- K221904 — EK12 V2 Algorithm
- K221321 — MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System
- K220732 — Mural Perinatal Surveillance
- K213234 — CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Model Number MKT101, CARESCAPE PRES, Model Number MKP101, CARESCAPE SPO2, Model Numbers MKS101 and MKS201
- K213490 — Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P
- K203786 — MAC 7 - Resting ECG Analysis System
- K202189 — Graffiti
- K201941 — Monitor B125, Monitor B105
- K173830 — MAC VU360 Resting ECG Analysis System
- K170155 — EK12 Algorithm
- K152993 — MUSE Cardiology Information System
- K141963 — 12SL ECG ANALYSIS PROGRAM
- K133882 — CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO)
- K132437 — MARS HOLTER ANALYSIS WORKSTATION
- K130626 — MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYS
- K123996 — RADIAL-CUF NON-INVASIVE BLOOD PRESSURE CUFF
- K130155 — MUSE CARDIOLOGY INFORMATION SYSTEM
- K120125 — SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUF
- K110132 — MUSE CARDIOLOGY INFORMATION SYSTEM
- K103765 — MAC 600 RESTING ECG ANALYSIS SYSTEM
- K110266 — MAC 5500 HD, MAC 3500
- K103432 — UNITY NETWORK ID
Data sourced from openFDA. This site is unofficial and independent of the FDA.