GE Medical Systems SCS
GE Medical Systems SCS appears in FDA public data with 1 recall, 38 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2553-2026, Class II) was initiated on May 8, 2026. Its most recent 510(k) clearance was granted on July 21, 2026.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 38
- Inspections
- 3
- Compliance Actions
- 0
Known Names
ge medical systems scs, ge medical systems, scs
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2553-2026 | Class II | GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System | May 8, 2026 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K253770 | CardIQ Suite | July 21, 2026 |
| K260087 | Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright | March 24, 2026 |
| K251199 | Allia Moveo | December 9, 2025 |
| K243672 | CardIQ Suite | June 18, 2025 |
| K243651 | VersaViewer | April 21, 2025 |
| K243446 | 3DXR | February 25, 2025 |
| K233731 | CardIQ Suite | August 1, 2024 |
| K233714 | BreView | January 25, 2024 |
| K232344 | Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR | October 11, 2023 |
| K223424 | Spine Auto Views | July 13, 2023 |
| K223490 | FlightPlan for Embolization | March 21, 2023 |
| K222895 | DynamicIQ | November 22, 2022 |
| K223152 | Vision 2, EVARVision, TrackVision 2, HeartVision 2 | November 22, 2022 |
| K211180 | Liver Suite | May 2, 2022 |
| K213725 | CardIQ Suite | March 11, 2022 |
| K210807 | FlightPlan for Liver | October 22, 2021 |
| K211247 | PET VCAR | July 27, 2021 |
| K200626 | VesselIQ Xpress | February 16, 2021 |
| K193306 | PROView | November 17, 2020 |
| K193289 | FastStroke, CT Perfusion 4D | November 12, 2020 |