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GE Healthcare FDA Recalls
24 recalls on file across devices, 0 of them Class I and 24 still open. Matched by name to GEHC.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Centricity PACS V2, V3, V4, V6, V7, software product is intended for the storage, reading, diagnostic review, analysis, Class IIJul 31, 2026Under certain conditions historical imaging data migrated fr |
| Core Services Hub V8, a set of backend services including Cross Enterprise (XE) and Workflow Core (WFC) services that enClass IIJul 31, 2026Under certain conditions historical imaging data migrated fr |
| Workflow Core Services V8, intended to provide set of services for storage and retrieval of patient data, exams and perfClass IIJul 31, 2026Under certain conditions historical imaging data migrated fr |
| Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versionsClass IIJul 31, 2026Under certain conditions historical imaging data migrated fr |
| Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical Class IIJul 31, 2026Under certain conditions historical imaging data migrated fr |
| Centricity PACS Server V7, intended for managing digital medical images and associated data, All versionsClass IIJul 31, 2026Under certain conditions historical imaging data migrated fr |
| GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047; Class IIJan 16, 2026Under certain workflows, patient information shown in the vi |
| GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers: 1) 2049587-015; 2) 2066908-086; Class IIFeb 19, 2025There is a potential security vulnerability in Centricity Un |
| GE Healthcare Centricity Universal Viewer (UV), Model Numbers: 1) 2066908-077; 2) 2066908-136; 3) 2066908-150; 4) Class IIFeb 19, 2025There is a potential security vulnerability in Centricity Un |
| GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-001; 2) 2033901-001; 3) 2038437-001; Class IIFeb 19, 2025There is a potential security vulnerability in Centricity Un |
| GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2) 2038437-001; 3) 2038437-00Class IIFeb 19, 2025There is a potential security vulnerability in Centricity Un |
| GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001; 2) 2049587-009; 3) 2049587-011; 4) 2Class IIFeb 19, 2025There is a potential security vulnerability in Centricity Un |
| GE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers: 1) 2089507-083, GDZH-JINWAN-Centricity 2) 2Class IIOct 3, 2024GE HealthCare has become aware of an issue in Centricity Uni |
| GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/Code Numbers: a)¿¿¿¿¿ 2089507-120; bClass IIAug 29, 2024GE HealthCare has become aware of an issue in Centricity Uni |
| GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.Class IIAug 5, 2024GE HealthCare has become aware of an issue where image stora |
| GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: a) 2110344-008; b) 2110344-009; Class IIJul 23, 2024Footprint Client (ZFP) versions v6.0 SP9.x and SP10.x where |
| Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation; Radiological Image Processing SystemClass IISep 14, 2023GE HealthCare has become aware of an issue where images from |
| Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Radiological Image Processing SystemClass IISep 14, 2023GE HealthCare has become aware of an issue where images from |
| Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiological Image Processing SystemClass IISep 14, 2023GE HealthCare has become aware of an issue where images from |
| Centricity Universal Viewer Workflow Manager, Image processing radiological systemClass IISep 8, 2023When using Universal Viewer or Centricity Universal Viewer w |
| Universal Viewer Workflow Manager, Image processing radiological systemClass IISep 8, 2023When using Universal Viewer or Centricity Universal Viewer w |
| Centricity PACS-IW with Universal Viewer, Model/Catalog Numbers: a) 2066908-061, b) 2066908-077, c) 2066908-086, d) 206Class IIMar 28, 2023GE HealthCare has become aware of an issue where information |
| Centricity Universal Viewer, Centricity Universal Viewer 6.0, Model/Catalog Numbers: a) 2088026-003, b) 2088026-026,Class IIMar 28, 2023GE HealthCare has become aware of an issue where information |
| Centricity PACS-IW, Product ID Numbers: a) 2041037-001, b) 2042988-001, c) 2049587-009, d) 2049587-011, e) 2049587-012,Class IIMar 28, 2023GE HealthCare has become aware of an issue where information |