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GE Medical Systems Information Technologies Inc

FDA Regulatory Profile

GE Medical Systems Information Technologies Inc appears in FDA public data with 20 recalls, 171 510(k) clearances, 7 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-3143-2026, Class II) was initiated on July 30, 2026. Its most recent 510(k) clearance was granted on July 24, 2026.

Summary

Total Recalls
20
510(k) Clearances
171
Inspections
7
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-3143-2026Class IICarescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04, 5867474-13 Product codJuly 30, 2026
Z-3038-2026Class IIPORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353July 20, 2026
Z-3039-2026Class IIFRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225July 20, 2026
Z-3036-2026Class IIPORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209July 20, 2026
Z-3037-2026Class IIPORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592July 20, 2026
Z-2878-2026Class IIGE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring systemJuly 10, 2026
Z-2876-2026Class IIGE Healthcare MAC VU360, REF# part number 2030361-023; ElectrocardiographJune 29, 2026
Z-2242-2026Class IIGE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product Code SS9; used in cApril 24, 2026
Z-2279-2026Class IICASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3April 24, 2026
Z-2243-2026Class IIGE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by GE Service April 24, 2026
Z-2246-2026Class IIGE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, ProduApril 24, 2026
Z-2247-2026Class IIGE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV; used in conjunction wApril 24, 2026
Z-2244-2026Class IIGE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER, REF #2108729-901, Product Code SS9; ApexPApril 24, 2026
Z-2245-2026Class IIGE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product Code KSA; April 24, 2026
Z-1938-2025Class IIMUSE 5 Systems, Model Numbers 2021274-001, 2023032-005, 2027478-001, Large capacity client-server-baApril 25, 2025
Z-2258-2024Class IIPrucka 3 Amplifier Model #P1801PA used with CardioLab AltiX electrophysiology recording system and CApril 22, 2024
Z-2027-2024Class IIGE HealthCare CRITIKON ONE-CUF blood pressure cuffs, Model numbers: 1. ONE-A1-1B, ONE-CUF, SMALLApril 9, 2024
Z-2613-2023Class IIPrucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CaAugust 8, 2023
Z-0487-2018Class IIGE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2 The CARESCAPE Central StaJanuary 11, 2018
Z-0202-2018Class IICARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650, and B450 July 13, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K253277Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PJuly 24, 2026
K251670MAC 7 Resting ECG Analysis SystemJanuary 26, 2026
K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PJuly 9, 2025
K243540Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.December 12, 2024
K233810Portrait VSMApril 25, 2024
K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application (PortraitMarch 20, 2024
K231870CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing SystemDecember 13, 2023
K230626Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services (Portrait CSS01), PAugust 11, 2023
K230145ONE-CUFMarch 14, 2023
K222586Mural Clinical ViewerDecember 21, 2022
K221904EK12 V2 AlgorithmDecember 20, 2022
K221321MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis SystemOctober 18, 2022
K220732Mural Perinatal SurveillanceJune 23, 2022
K213234CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKApril 12, 2022
K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PApril 1, 2022
K203786MAC 7 - Resting ECG Analysis SystemApril 30, 2021
K202189GraffitiDecember 8, 2020
K201941Monitor B125, Monitor B105November 4, 2020
K173830MAC VU360 Resting ECG Analysis SystemSeptember 18, 2018
K170155EK12 AlgorithmJune 6, 2017

FDA data resources