Ge Healthcare
Ge Healthcare appears in FDA public data with 573 recalls — including 42 Class I (most serious) —, 169 510(k) clearances, 37 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-3168-2026, Class II) was initiated on July 31, 2026. Its most recent 510(k) clearance was granted on January 8, 2026.
Summary
- Total Recalls
- 573 (42 Class I)
- 510(k) Clearances
- 169
- Inspections
- 37
- Compliance Actions
- 0
Known Names
ge healthcare, ge healthcare (china) co, ge healthcare japan corporation, g.e. healthcare
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-3168-2026 | Class II | Centricity PACS V2, V3, V4, V6, V7, software product is intended for the storage, reading, diagnosti | July 31, 2026 |
| Z-3167-2026 | Class II | Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical dat | July 31, 2026 |
| Z-3170-2026 | Class II | Workflow Core Services V8, intended to provide set of services for storage and retrieval of patient | July 31, 2026 |
| Z-3166-2026 | Class II | Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending | July 31, 2026 |
| Z-3171-2026 | Class II | Core Services Hub V8, a set of backend services including Cross Enterprise (XE) and Workflow Core (W | July 31, 2026 |
| Z-3169-2026 | Class II | Centricity PACS Server V7, intended for managing digital medical images and associated data, All ver | July 31, 2026 |
| Z-1767-2026 | Class II | SIGNA Premier systems | February 27, 2026 |
| Z-1475-2026 | Class II | GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 211034 | January 16, 2026 |
| Z-0935-2026 | Class II | GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system | November 3, 2025 |
| Z-1483-2025 | Class II | GE Healthcare Centricity Universal Viewer (UV), Model Numbers: 1) 2066908-077; 2) 2066908-136; 3 | February 19, 2025 |
| Z-1487-2025 | Class II | GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers: 1) 2049587-015; | February 19, 2025 |
| Z-1486-2025 | Class II | GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2) 2038437- | February 19, 2025 |
| Z-1485-2025 | Class II | GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-001; 2) 2033901-001 | February 19, 2025 |
| Z-1484-2025 | Class II | GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001; 2) 2049587-009; 3) | February 19, 2025 |
| Z-0318-2025 | Class II | GE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers: 1) 2089507-083, GDZH-JIN | October 3, 2024 |
| Z-0039-2025 | Class II | GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/Code Numbers: a)¿¿ | August 29, 2024 |
| Z-3145-2024 | Class II | ViewPoint; system, imaging processing, radiological | August 8, 2024 |
| Z-3146-2024 | Class II | ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47 | August 8, 2024 |
| Z-3214-2024 | Class II | GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system. | August 5, 2024 |
| Z-3160-2024 | Class II | GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: a) 2110344-008; | July 23, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K253639 | View | January 8, 2026 |
| K242925 | MR Contour DL | April 1, 2025 |
| K241300 | ViewPoint 6 | July 2, 2024 |
| K232346 | Digital Expert Access with Remote Scanning | October 27, 2023 |
| K223212 | Precision DL | April 27, 2023 |
| K221680 | Xeleris V Processing and Review System | March 1, 2023 |
| K221932 | Omni Legend | September 2, 2022 |
| K213689 | Voluson P6, Voluson P8 | February 17, 2022 |
| K213642 | Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert | January 13, 2022 |
| K211488 | LOGIQ E10 | September 10, 2021 |
| K212004 | MyoSPECT, MyoSpect ES | August 27, 2021 |
| K211524 | LOGIQ E10s, LOGIQ Fortis | August 27, 2021 |
| K211725 | Senographe Pristina | August 6, 2021 |
| K211215 | SenoBright HD | June 22, 2021 |
| K211312 | Universal Viewer | May 21, 2021 |
| K210173 | StarGuide | March 29, 2021 |
| K201628 | Panda iRes Warmer, Giraffe Warmer | February 12, 2021 |
| K201768 | Voluson E10 | October 22, 2020 |
| K201103 | Xeleris V Processing and Review Systems | September 25, 2020 |
| K193334 | Pristina Serena Bright | May 15, 2020 |