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GE Medical Systems Information Technologies, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 170
- Inspections
- 7
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1938-2025 | Class II | MUSE 5 Systems, Model Numbers 2021274-001, 2023032-005, 2027478-001, Large capacity client-server-ba | April 25, 2025 |
| Z-2258-2024 | Class II | Prucka 3 Amplifier Model #P1801PA used with CardioLab AltiX electrophysiology recording system and C | April 22, 2024 |
| Z-2027-2024 | Class II | GE HealthCare CRITIKON ONE-CUF blood pressure cuffs, Model numbers: 1. ONE-A1-1B, ONE-CUF, SMALL | April 9, 2024 |
| Z-2613-2023 | Class II | Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with Ca | August 8, 2023 |
| Z-0487-2018 | Class II | GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2 The CARESCAPE Central Sta | January 11, 2018 |
| Z-0202-2018 | Class II | CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650, and B450 | July 13, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K251670 | MAC 7 Resting ECG Analysis System | January 26, 2026 |
| K242562 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P | July 9, 2025 |
| K243540 | Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI. | December 12, 2024 |
| K233810 | Portrait VSM | April 25, 2024 |
| K234130 | Portrait Mobile Monitoring Solution consists of: Portrait Central Viewer Application (Portrait | March 20, 2024 |
| K231870 | CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System | December 13, 2023 |
| K230626 | Portrait Central Viewer Application (Portrait CV A01), Portrait Core Services (Portrait CSS01), P | August 11, 2023 |
| K230145 | ONE-CUF | March 14, 2023 |
| K222586 | Mural Clinical Viewer | December 21, 2022 |
| K221904 | EK12 V2 Algorithm | December 20, 2022 |
| K221321 | MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System | October 18, 2022 |
| K220732 | Mural Perinatal Surveillance | June 23, 2022 |
| K213234 | CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MK | April 12, 2022 |
| K213490 | Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P | April 1, 2022 |
| K203786 | MAC 7 - Resting ECG Analysis System | April 30, 2021 |
| K202189 | Graffiti | December 8, 2020 |
| K201941 | Monitor B125, Monitor B105 | November 4, 2020 |
| K173830 | MAC VU360 Resting ECG Analysis System | September 18, 2018 |
| K170155 | EK12 Algorithm | June 6, 2017 |
| K152993 | MUSE Cardiology Information System | January 12, 2016 |