GE Healthcare
GE Healthcare holds FDA 510(k) medical device clearances, first cleared 2004, most recent 2026, with 89 FDA device recalls on record.
Top product codes for GE Healthcare
FDA recalls by GE Healthcare
10 most recent of 89- Z-1475-2026 — GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047; System, Image Processing, Radiological
- Z-1486-2025 — GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2) 2038437-001; 3) 2038437-009; 4) 2038437-014; 5) 2038437-015 ; 6) 2038437-0XX; 7) 2109571-007; 8) 2109571-010; 9) 2109571-011; 10) 2109571-012; 11) MANLEGACY111; 12) MANLEGACY112; 13) MANLEGACY47; 14) P00011TS.
- Z-1487-2025 — GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers: 1) 2049587-015; 2) 2066908-086; 3) 2066908-136; 4) 2104867-045.
- Z-1485-2025 — GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-001; 2) 2033901-001; 3) 2038437-001; 4) 2038437-011; 5) 2038437-012; 6) 2038437-013; 7) 2038437-014; 8) 2038437-0XX; 9) 2098071-004; 10) 2109571-002; 11) 2109571-006; 12) 2109571-010; 13) 2109594-009; 14) 2109594-011; 15) K2090PS; 16) K2090PTED; 17) MANLEGACY114; 18) MANLEGACY64.
- Z-1484-2025 — GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001; 2) 2049587-009; 3) 2049587-011; 4) 2049587-012; 5) 2049587-015; 6) 2049588-012 ; 7) 2052829-001.
- Z-1483-2025 — GE Healthcare Centricity Universal Viewer (UV), Model Numbers: 1) 2066908-077; 2) 2066908-136; 3) 2066908-150; 4) 2088026-003; 5) 2088026-026; 6) 2088026-032; 7) 2088026-043; 8) 2088026-110; 9) 2088026-115; 10) 2088026-132; 11) 2088026-306; 12) 2088026-308; 13) 2088026-406; 14) 2088026-506; 15) 2088026-614; 16) 2088026-713; 17) 2088026-714; 18) 2088026-715; 19) 2088026-723; 20) 2088026-806; 21) 2088026-906; 22) 2088026-936; 23) 2088026-940; 24) 2088026-943; 25) 2088026-946; 26) 2088026-948; 27) 2088026-957; 28) 2088026-959; 29) 2088026-960; 30) 2088026-961; 31) 2088026-962; 32) 2088026-967; 33) 2088026-969; 34) 2088026-970; 35) 2088026-971; 36) 2088026-973; 37) 2088026-985; 38) 2088026-989; 39) 2088026-990; 40) 2088026-993; 41) 2088026-994; 42) 2089629-003; 43) 2100169-001; 44) 2100491-006; 45) 2100491-012; 46) 2102675-010; 47) 2102675-101; 48) 2102676-001; 49) 2104867-001; 50) 2104867-044; 51) 2104867-045; 52) 2111141-004; 53) 5826659-002; 54) 5826659-013; 55) 5826659-014; 56) 5826659-016; 57) 5826659-017; 58) 5826659-018; 59) 5826659-019; 60) 5826659-021; 61) 5826659-022; 62) 5826659-023; 63) 5826659-025; 64) 5826659-026; 65) 5826659-027; 66) 5826659-028; 67) 5826659-029; 68) 5826659-030; 69) 5826659-032; 70) 5826659-033; 71) K1220JWED; 72) K2042VJED.
- Z-0318-2025 — GE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers: 1) 2089507-083, GDZH-JINWAN-Centricity 2) 2089507-093, 10510-3-Centricity Universal Viewer Zero Footprint / ZFP-02268286, 10510-3-Centricity Universal Viewer Zero Footprint / ZFP-02030900, 1495-1-Centricity Universal Viewer Zero Footprint / ZFP-02347996, 423834-Centricity Universal Viewer Zero Footprint / ZFP-02286658, 1407636-Centricity Universal Viewer Zero Footprint / ZFP-02304121, 651240-Centricity Universal Viewer Zero Footprint / ZFP-02173181, 268034-Centricity Universal Viewer Zero Footprint / ZFP-02402520; 3) 2089507-098, JP-310027-Centricity Universal Viewer Zero Footprint / ZFP-02033125; 4) 2089507-109, 3909-2-Centricity Universal Viewer Zero Footprint / ZFP-20095312, 3909-2-Centricity Universal Viewer Zero Footprint / ZFP-20095313, 327750-Centricity Universal Viewer Zero Footprint / ZFP-02184508; 5) 2089507-111, 105468-1-Centricity Universal Viewer Zero Footprint / ZFP-02254840, 1495-3-Centricity Universal Viewer Zero Footprint / ZFP-00096090, JP-340111-Centricity Universal Viewer Zero Footprint / ZFP-01275379, JP-275353-Centricity Universal Viewer Zero Footprint / ZFP-02042636; 6) 2089507-112, 3922-25-Centricity Universal Viewer Zero Footprint / ZFP-01290685, 3922-17-Centricity Universal Viewer Zero Footprint / ZFP-00098229, 1503586-Centricity Universal Viewer Zero Footprint / ZFP-21016603, RU0994-Centricity Universal Viewer Zero Footprint / ZFP-02331255; 7) 2089507-114, 1461-1-Centricity Universal Viewer Zero Footprint / ZFP-02360229, 1461-1-Centricity Universal Viewer Zero Footprint / ZFP-01803680, 3728-2-Centricity Universal Viewer Zero Footprint / ZFP-01225897, 3728-2-Centricity Universal Viewer Zero Footprint / ZFP-01225898, 3728-2-Centricity Universal Viewer Zero Footprint / ZFP-01225904, 3728-2-Centricity Universal Viewer Zero Footprint / ZFP-01371500, M51725-Centricity Universal Viewer Zero Footprint / ZFP-01300873, M1781854-Centricity Universal Viewer Zero Footprint / ZFP-01553772, 609334-Centricity Universal Viewer Zero Footprint / ZFP-01282257, UJJF01-Centricity Universal Viewer Zero Footprint / ZFP-22186138, CMC-Centricity Universal Viewer Zero Footprint / ZFP-01820241, JP-100014-Centricity Universal Viewer Zero Footprint / ZFP-01890709, KW1102-Centricity Universal Viewer Zero Footprint / ZFP-02191178, 59219_ERPerror-Centricity Universal Viewer Zero Footprint / ZFP-02327073, QA1114-Centricity Universal Viewer Zero Footprint / ZFP-02306397, SAU1433-Centricity Universal Viewer Zero Footprint / ZFP-01457278, TTSH-CVIS-Centricity Universal Viewer Zero Footprint / ZFP-02041523, NE4651-Centricity Universal Viewer Zero Footprint / ZFP-00038599, NE6703-Centricity Universal Viewer Zero Footprint / ZFP-00038552, NE6731-Centricity Universal Viewer Zero Footprint / ZFP-00038461, NE3006-Centricity Universal Viewer Zero Footprint / ZFP-00038362, NE2196-Centricity Universal Viewer Zero Footprint / ZFP-00038588, NPV738-Centricity Universal Viewer Zero Footprint / ZFP-00038637, NE2031-Centricity Universal Viewer Zero Footprint / ZFP-00038578, NE7405-Centricity Universal Viewer Zero Footprint / ZFP-00038372, NE2162-Centricity Universal Viewer Zero Footprint / ZFP-00038563, NE4878-
- Z-0039-2025 — GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/Code Numbers: a)¿¿¿¿¿ 2089507-120; b)¿¿¿¿ 2089507-129; c)¿¿¿¿¿ 2089507-131; d)¿¿¿¿ 2089507-135; e)¿¿¿¿ 2089507-136; f)¿¿¿¿¿¿ 2089507-140; g)¿¿¿¿¿ 2089507-144; h)¿¿¿¿ 2089507-145; i)¿¿¿¿¿¿ 2089507-149; j)¿¿¿¿¿¿ 2089507-153; k)¿¿¿¿¿ 2089507-154; l)¿¿¿¿¿¿ 2089507-155; m)¿¿¿ 2089507-156; n)¿¿¿¿ 2089507-157; o)¿¿¿¿ K2037DAED; p)¿¿¿¿ K2037DBED; q)¿¿¿¿ K2037DED; r)¿¿¿¿¿ K2037DJED; s)¿¿¿¿¿ K2037DNED; t)¿¿¿¿¿ K2042TTED; u)¿¿¿¿ K2049DC; v)¿¿¿¿¿ K2049DD; w)¿¿¿ K2049DF; x)¿¿¿¿¿ P2037DAED; y)¿¿¿¿¿ P2037DBED; z)¿¿¿¿¿ P2037DED; aa)¿¿ To be provided
- Z-3214-2024 — GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.
- Z-3160-2024 — GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: a) 2110344-008; b) 2110344-009; c) 2110344-010; d) 2110344-011; e) 2110344-013; f) 2110344-019; g) 2110344-025; h) 2110344-029; i) 2110344-030; j) 2110344-032 ; Radiological image processing system
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by GE Healthcare
1–100 of 168- K253639 — View
- K242925 — MR Contour DL
- K232346 — Digital Expert Access with Remote Scanning
- K223212 — Precision DL
- K221680 — Xeleris V Processing and Review System
- K221932 — Omni Legend
- K213689 — Voluson P6, Voluson P8
- K213642 — Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert
- K211488 — LOGIQ E10
- K211524 — LOGIQ E10s, LOGIQ Fortis
- K212004 — MyoSPECT, MyoSpect ES
- K211725 — Senographe Pristina
- K211215 — SenoBright HD
- K211312 — Universal Viewer
- K210173 — StarGuide
- K201628 — Panda iRes Warmer, Giraffe Warmer
- K201768 — Voluson E10
- K201103 — Xeleris V Processing and Review Systems
- K193334 — Pristina Serena Bright
- K200494 — CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES
- K190008 — Carescape One
- K192159 — Voluson E6, Voluson E8, Voluson E10
- K190809 — Sample Imaging for Senographe Pristina
- K182951 — Pristina Serena 3D
- K182419 — Centricity Universal Viewer
- K183116 — Unity Network ID
- K181985 — Voluson E6, Voluson E8, Voluson E10
- K181403 — Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR
- K182590 — 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA
- K181783 — LOGIQ P9; LOGIQ P7
- K173576 — Pristina Serena
- K180641 — Invenia ABUS Viewer
- K173816 — NM/CT 850, NM/CT 860
- K180535 — Voluson P6 and Voluson P8
- K180374 — Voluson S8/ Voluson S10/ Voluson S10 Expert
- K173555 — LOGIQ E10
- K172404 — SenoBright HD
- K172342 — Voluson E6, Voluson E8, Voluson E10
- K163302 — Senographe Pristina
- K170199 — Unity Network ID
- K170445 — LOGIQ S8
- K163596 — LOGIQ P9 and LOGIQ P7
- K160933 — Discovery NM 750b Bopsy
- K162268 — Senographe Pristina
- K162269 — Voluson E6, Voluson E8, Voluson E10
- K162012 — CARESCAPE Central Station V2
- K161567 — SIGNA Voyager
- K160937 — Senolris
- K161047 — LOGIQ P9 and LOGIQ P7
- K160162 — Voluson P6, Voluson P8
- K160621 — SIGNAPioneer
- K153355 — Xeleris 4.0 Processing and Review Workstation
- K160182 — LOGIQ S7 Expert
- K160184 — Voluson S6, Voluson S8, Voluson S10
- K153402 — Discovery NM/CT 670 CZT
- K152567 — Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System
- K153003 — SIGNA Pioneer
- K152195 — LOGIQ S8
- K150420 — Centricity Universal Viewer
- K143361 — Mammo Workstation
- K142472 — Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems
- K143452 — LOGIQ P9, LOGIQ P7
- K142840 — Unity Network ID
- K142160 — LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM
- K141768 — LOGIQ V5/LOGIQ V3
- K141675 — VOLUSON P6, VOLUSON P8
- K141639 — VOLUSON S6, VOLUSON S8
- K141261 — LOGIQ S7 EXPERT, LOGIQ S7 PRO
- K141067 — VIVID T8/VIVID T8 PRO
- K133533 — LOGIQ E
- K133034 — LOGIQ F SERIES
- K133431 — VENUE 50
- K132913 — VOLUSON E6 / E8 / E8EXPERT / E8EXPERT LIMITED EDITION / E10
- K131937 — VOLUSON I/E
- K131977 — CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT CLIENT
- K131527 — LOGIQ S8
- K131267 — VOLUSON E6/E8/E8EXPERT/E8EXPERT LIMITED EDITION/E10
- K131118 — 4D VIEW
- K130069 — INNOVA EPVISION 2.0, INNOVA EPVISION 2.0
- K122457 — GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY SYSTEMS WITH CATHLAB FRONTIERS SOLUTIONS
- K123564 — LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM
- K123174 — CENTRICITY PACS-IW WITH UNIVERSAL VIEWER
- K121200 — FLIGHTPLAN FOR LIVER
- K122921 — C1-6-D ULTRASOUND TRANSDUCER
- K122114 — LOGIQ S7 EXPERT, LOGIQ S7 PRO
- K122327 — VOLUSON E6/E8/E8EXPERT/E10
- K122387 — VOLUSON P6, VOLUSON P8
- K122515 — C2-9-D ULTRASOUND TRANSDUCER
- K120741 — VOLUSON S6, VOLUSON S8
- K121019 — OPTIMA NM/CT 640
- K120221 — GE ECHOPAC
- K113758 — VOLUSON E6/E8/E8EXPERT/E10
- K113690 — GE LOGIQ I, LOGIQ E AND VIVID E
- K113034 — GE INNOVA SOLID STATE XRAY IMAGER FLUROSOPIC X RAY SYSTEM
- K113350 — BRIVO NM 615
- K111200 — MAC-LAB SYSTEM, CARDIOLAB SYSTEM, COMBOLAB SYSTEM, SPECIALSLAB SYSTEM
- K112371 — LOGIQ P3
- K112122 — VENUE 40
- K112213 — VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM
- K111209 — INTEGRATED INNOVA - S5I SYSTEM OPTION
Data sourced from openFDA. This site is unofficial and independent of the FDA.