GE Healthcare

FDA Regulatory Profile

Summary

Total Recalls
566 (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

NumberClassProductDate
Z-1475-2026Class IIGE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 211034January 16, 2026
Z-0935-2026Class IIGE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing systemNovember 3, 2025
Z-1486-2025Class IIGE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2) 2038437-February 19, 2025
Z-1487-2025Class IIGE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers: 1) 2049587-015;February 19, 2025
Z-1485-2025Class IIGE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-001; 2) 2033901-001February 19, 2025
Z-1483-2025Class IIGE Healthcare Centricity Universal Viewer (UV), Model Numbers: 1) 2066908-077; 2) 2066908-136; 3February 19, 2025
Z-1484-2025Class IIGE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001; 2) 2049587-009; 3)February 19, 2025
Z-0318-2025Class IIGE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers: 1) 2089507-083, GDZH-JINOctober 3, 2024
Z-0039-2025Class IIGE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/Code Numbers: a)¿¿August 29, 2024
Z-3145-2024Class IIViewPoint; system, imaging processing, radiologicalAugust 8, 2024
Z-3146-2024Class IIViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47August 8, 2024
Z-3214-2024Class IIGE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.August 5, 2024
Z-3160-2024Class IIGE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: a) 2110344-008; July 23, 2024
Z-0138-2024Class IICentricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiological Image Processing SystSeptember 14, 2023
Z-0140-2024Class IICentricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Radiological Image ProcessSeptember 14, 2023
Z-0139-2024Class IICentricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation; Radiological ImaSeptember 14, 2023
Z-0142-2024Class IICentricity Universal Viewer Workflow Manager, Image processing radiological systemSeptember 8, 2023
Z-0143-2024Class IIUniversal Viewer Workflow Manager, Image processing radiological systemSeptember 8, 2023
Z-1502-2023Class IICentricity PACS-IW, Product ID Numbers: a) 2041037-001, b) 2042988-001, c) 2049587-009, d) 2049587-March 28, 2023
Z-1500-2023Class IICentricity PACS-IW with Universal Viewer, Model/Catalog Numbers: a) 2066908-061, b) 2066908-077, c)March 28, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K253639ViewJanuary 8, 2026
K242925MR Contour DLApril 1, 2025
K241300ViewPoint 6July 2, 2024
K232346Digital Expert Access with Remote ScanningOctober 27, 2023
K223212Precision DLApril 27, 2023
K221680Xeleris V Processing and Review SystemMarch 1, 2023
K221932Omni LegendSeptember 2, 2022
K213689Voluson P6, Voluson P8February 17, 2022
K213642Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 ExpertJanuary 13, 2022
K211488LOGIQ E10September 10, 2021
K212004MyoSPECT, MyoSpect ESAugust 27, 2021
K211524LOGIQ E10s, LOGIQ FortisAugust 27, 2021
K211725Senographe PristinaAugust 6, 2021
K211215SenoBright HDJune 22, 2021
K211312Universal ViewerMay 21, 2021
K210173StarGuideMarch 29, 2021
K201628Panda iRes Warmer, Giraffe WarmerFebruary 12, 2021
K201768Voluson E10October 22, 2020
K201103Xeleris V Processing and Review SystemsSeptember 25, 2020
K193334Pristina Serena BrightMay 15, 2020