Company ยท US
GE Healthcare, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2026. Name variants (Inc, Corp, punctuation) are merged.
169510(k) clearances (1 in 12 months)
793recalls (9 in 12 months)
684recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | 128 |
| LLZ | System, Image Processing, Radiological | 107 |
| JAK | System, X-Ray, Tomography, Computed | 103 |
| KPS | System, Tomography, Computed, Emission | 87 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 67 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 62 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 47 |
| BSZ | Gas-Machine, Anesthesia | 41 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 34 |
| IZI | System, X-Ray, Angiographic | 28 |
| FMT | Warmer, Infant Radiant | 20 |
| KPR | System, X-Ray, Stationary | 20 |
| OWB | Interventional Fluoroscopic X-Ray System | 20 |
| MUE | Full Field Digital, System, X-Ray, Mammographic | 18 |
| IZL | System, X-Ray, Mobile | 14 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 11 |
| DQK | Computer, Diagnostic, Programmable | 10 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 10 |
| KGI | Densitometer, Bone | 9 |
| MSX | System, Network And Communication, Physiological Monitors | 9 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 8, 2026 | K253639 | View GE Healthcare | LLZ |
| Apr 1, 2025 | K242925 | MR Contour DL GE Healthcare | QKB |
| Jul 2, 2024 | K241300 | ViewPoint 6 Ge Healthcare GmbH, DE | LLZ |
| Oct 27, 2023 | K232346 | Digital Expert Access with Remote Scanning GE Healthcare | LNH |
| Apr 27, 2023 | K223212 | Precision DL GE Healthcare, IL | KPS |
| Mar 1, 2023 | K221680 | Xeleris V Processing and Review System GE Healthcare, IL | LLZ |
| Sep 2, 2022 | K221932 | Omni Legend GE Healthcare, IL | KPS |
| Feb 17, 2022 | K213689 | Voluson P6, Voluson P8 GE Healthcare | IYN |
| Jan 13, 2022 | K213642 | Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert GE Healthcare | IYN |
| Sep 10, 2021 | K211488 | LOGIQ E10 GE Healthcare | IYN |
| Aug 27, 2021 | K212004 | MyoSPECT, MyoSpect ES GE Healthcare, IL | KPS |
| Aug 27, 2021 | K211524 | LOGIQ E10s, LOGIQ Fortis GE Healthcare | IYN |
| Aug 6, 2021 | K211725 | Senographe Pristina GE Healthcare, FR | MUE |
| Jun 22, 2021 | K211215 | SenoBright HD GE Healthcare, FR | MUE |
| May 21, 2021 | K211312 | Universal Viewer GE Healthcare | LLZ |
| Mar 29, 2021 | K210173 | StarGuide GE Healthcare, IL | KPS |
| Feb 12, 2021 | K201628 | Panda iRes Warmer, Giraffe Warmer GE Healthcare | FMT |
| Oct 22, 2020 | K201768 | Voluson E10 GE Healthcare | IYN |
| Sep 25, 2020 | K201103 | Xeleris V Processing and Review Systems GE Healthcare, IL | LLZ |
| May 15, 2020 | K193334 | Pristina Serena Bright GE Healthcare, FR | MUE |
| Mar 29, 2020 | K200494 | CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES GE Healthcare | MHX |
| Dec 20, 2019 | K190008 | Carescape One GE Healthcare | MHX |
| Aug 29, 2019 | K192159 | Voluson E6, Voluson E8, Voluson E10 GE Healthcare | IYN |
| Jul 29, 2019 | K190809 | Sample Imaging for Senographe Pristina GE Healthcare, FR | MUE |
| Jan 18, 2019 | K182951 | Pristina Serena 3D GE Healthcare, FR | MUE |
| Dec 14, 2018 | K182419 | Centricity Universal Viewer GE Healthcare | LLZ |
| Dec 6, 2018 | K183116 | Unity Network ID GE Healthcare | MWI |
| Nov 15, 2018 | K181985 | Voluson E6, Voluson E8, Voluson E10 GE Healthcare | IYN |
| Nov 2, 2018 | K181403 | Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR GE Healthcare, FR | OWB |
| Oct 19, 2018 | K182590 | 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA GE Healthcare | MOS |
| Sep 20, 2018 | K181783 | LOGIQ P9; LOGIQ P7 GE Healthcare | IYN |
| May 14, 2018 | K173576 | Pristina Serena GE Healthcare, FR | MUE |
| May 4, 2018 | K180641 | Invenia ABUS Viewer GE Healthcare | LLZ |
| Apr 17, 2018 | K173816 | NM/CT 850, NM/CT 860 GE Healthcare, IL | KPS |
| Mar 29, 2018 | K180535 | Voluson P6 and Voluson P8 GE Healthcare | IYN |
| Mar 13, 2018 | K180374 | Voluson S8/ Voluson S10/ Voluson S10 Expert GE Healthcare | IYN |
| Dec 20, 2017 | K173555 | LOGIQ E10 GE Healthcare | IYN |
| Oct 30, 2017 | K172404 | SenoBright HD GE Healthcare, FR | MUE |
| Sep 29, 2017 | K172342 | Voluson E6, Voluson E8, Voluson E10 GE Healthcare | IYN |
| Sep 1, 2017 | K163302 | Senographe Pristina GE Healthcare, FR | MUE |
| May 12, 2017 | K170199 | Unity Network ID GE Healthcare | MWI |
| Apr 11, 2017 | K170445 | LOGIQ S8 GE Healthcare | IYN |
| Feb 10, 2017 | K163596 | LOGIQ P9 and LOGIQ P7 GE Healthcare | IYN |
| Nov 18, 2016 | K160933 | Discovery NM 750b Bopsy GE Healthcare, IL | IYX |
| Nov 3, 2016 | K162268 | Senographe Pristina GE Healthcare, FR | MUE |
| Oct 3, 2016 | K162269 | Voluson E6, Voluson E8, Voluson E10 GE Healthcare | IYN |
| Sep 15, 2016 | K162012 | CARESCAPE Central Station V2 GE Healthcare | DXJ |
| Sep 1, 2016 | K161567 | SIGNA Voyager GE Healthcare | LNH |
| Aug 1, 2016 | K160937 | Senolris GE Healthcare, DE | LLZ |
| May 5, 2016 | K161047 | LOGIQ P9 and LOGIQ P7 GE Healthcare | IYN |
Newest 50 of 169.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 15, 2026 | GE Healthcare Core Services Hub V8, a set of backend services including Cross Enterprise (XE) and Workflow Core (WFC) services that enables enterprise imaging workflows, All versions Open, Classified |
LLZ | K043415 K110875 |
| Sep 15, 2026 | GE Healthcare Workflow Core Services V8, intended to provide set of services for storage and retrieval of patient data, exams and performs system Administration, common configuration management for consuming applic Open, Classified |
LLZ | K043415 K110875 |
| Sep 15, 2026 | GE Healthcare Centricity PACS Server V7, intended for managing digital medical images and associated data, All versions Open, Classified |
LLZ | K043415 K110875 |
| Sep 15, 2026 | GE Healthcare Centricity PACS V2, V3, V4, V6, V7, software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images an Open, Classified |
LLZ | K043415 K110875 |
| Sep 15, 2026 | GE Healthcare Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versions Open, Classified |
LLZ | K043415 K110875 |
| Sep 15, 2026 | GE Healthcare Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical data, All Versions Open, Classified |
LLZ | K043415 K110875 |
| Apr 2, 2026 | GE Healthcare LLC SIGNA Premier systems Open, Classified |
LNH | K171128 K183231 +1 |
| Feb 27, 2026 | GE Healthcare GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047; System, Image Processing, Radiological Open, Classified |
LLZ | K131977 |
| Dec 16, 2025 | GE Healthcare GmbH GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system Open, Classified |
LLZ | K241300 |
| Mar 28, 2025 | GE Healthcare GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers:
1) 2049587-015;
2) 2066908-086;
3) 2066908-136;
4) 2104867-045. Open, Classified |
LLZ | None listed |
| Mar 28, 2025 | GE Healthcare 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 Open, Classified |
LLZ | K042525 K063628 |
| Mar 28, 2025 | GE Healthcare 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 Open, Classified |
LLZ | K042525 K063628 |
| Mar 28, 2025 | GE Healthcare 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. Open, Classified |
LLZ | K123174 |
| Mar 28, 2025 | GE Healthcare 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 Open, Classified |
LLZ | K150420 K182419 |
| Nov 7, 2024 | GE Healthcare 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, 105 Open, Classified |
LLZ | K131977 |
| Oct 9, 2024 | GE Healthcare 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) Open, Classified |
LLZ | K131977 |
| Sep 24, 2024 | GE Healthcare GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system. Open, Classified |
LLZ | K043415 K110875 |
| Sep 17, 2024 | GE Healthcare 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; Open, Classified |
LLZ | K131977 |
| Sep 13, 2024 | GE Healthcare GmbH ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, h) H47591YA; system, imaging processing, radiological Open, Classified |
LLZ | K103458 K162743 +4 |
| Sep 13, 2024 | GE Healthcare GmbH ViewPoint; system, imaging processing, radiological Open, Classified |
LLZ | K050943 |
| Oct 23, 2023 | GE Healthcare Universal Viewer Workflow Manager, Image processing radiological system Open, Classified |
LLZ | K211312 |
| Oct 23, 2023 | GE Healthcare Centricity Universal Viewer Workflow Manager, Image processing radiological system Open, Classified |
LLZ | K182419 |
| Oct 20, 2023 | GE Healthcare Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Radiological Image Processing System Open, Classified |
LLZ | K150420 |
| Oct 20, 2023 | GE Healthcare Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation; Radiological Image Processing System Open, Classified |
LLZ | K123174 |
| Oct 20, 2023 | GE Healthcare Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiological Image Processing System Open, Classified |
LLZ | K082318 |
| May 2, 2023 | GE Healthcare Centricity PACS-IW, Product ID Numbers: a) 2041037-001, b) 2042988-001, c) 2049587-009, d) 2049587-011, e) 2049587-012, f) 2049587-015, g) 2052829-001, h) Not applicable;
Radiological Image Processi Open, Classified |
LLZ | K082318 |
| May 2, 2023 | GE Healthcare Centricity Universal Viewer, Centricity Universal Viewer 6.0, Model/Catalog Numbers:
a) 2088026-003,
b) 2088026-026,
c) 2088026-032,
d) 2088026-043,
e) 2088026-044,
f) 2088026-115,
g) 2088026 Open, Classified |
LLZ | K150420 |
| May 2, 2023 | GE Healthcare Centricity PACS-IW with Universal Viewer, Model/Catalog Numbers: a) 2066908-061, b) 2066908-077, c) 2066908-086, d) 2066908-111, e) 2066908-123, f) 2066908-136, g) 2066908-150; Radiological Image Pro Open, Classified |
LLZ | K123174 |
| Aug 24, 2022 | GE Healthcare, LLC (1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3) GE Universal Viewer 8.0, Model 5865740-00x. Open, Classified |
LLZ | K150420 K182419 +1 |
| Aug 10, 2022 | GE Healthcare, LLC Service manuals for the CT, PET, or NM table as follows: GT1700/GT1700V/VT1700, GT2000/VT2000, GT2000x/VT2000x, High Capacity Table, Lite Table, Kunlun Table, Global PET-CT Table, NP Table, P2005AA Ta Open, Classified |
IZZ | None listed |
| Jul 19, 2022 | GE Healthcare, LLC GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia System, Part number 1009-9050-000. Terminated |
BSZ | K172045 |
| Jul 5, 2022 | GE Healthcare, LLC GE Centricity Universal Viewer Zero Footprint. To view, communicate, process, and display Medical images and data within a computer network or on a workstation. Open, Classified |
LLZ | K131977 |
| Jun 24, 2022 | GE Healthcare, LLC SIGNA Premier magnetic resonance scanner, model 5748519. Open, Classified |
LNH | K171128 K183231 +1 |
| Jun 14, 2022 | GE Healthcare, LLC Centricity PACS Software Version 7.0 SP0.0.4.7 Terminated |
LLZ | K110875 |
| Jun 13, 2022 | GE Healthcare, LLC CARESCAPE Central Station (CSCS) V2, Model numbers 2082278-001 and 2082279-001.
Update 3/10/2023: The following FRU and display part numbers have been added as affected devices:
(1) Part #2082294-0 Open, Classified |
DXJ | K162012 |
| Jun 6, 2022 | GE Healthcare, LLC Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstrom Carestation and Engstrom PRO Ventilators. Open, Classified |
CBK | K111116 K142679 |
| Jun 6, 2022 | GE Healthcare, LLC Back up batteries in Ventilators labeled as the following:
a. CARESCAPE R860 Ventilators (K142679)
b. ENGSTROM (K111116)
c. ENGSTROM Carestation (K111116)
d. ENGSTROM PRO (K111116) Open, Classified |
CBK | K111116 K142679 |
| Jun 3, 2022 | GE Healthcare, LLC Centricity PACS RA1000 Open, Classified |
LLZ | K110875 |
| Jun 3, 2022 | GE Healthcare, LLC Centricity Cardiology CA1000 Open, Classified |
LLZ | None listed |
| Jun 3, 2022 | GE Healthcare, LLC Centricity Radiology RA600 Open, Classified |
LLZ | K042525 K063628 |
| Jun 3, 2022 | GE Healthcare, LLC Centricity Enterprise Web Open, Classified |
LLZ | None listed |
| Jun 3, 2022 | GE Healthcare, LLC Centricity Universal Viewer Zero Footprint Client Open, Classified |
LLZ | K131977 |
| May 27, 2022 | GE Healthcare, LLC GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, Part # 1011-9050-000. Open, Classified |
BSZ | K172045 |
| Apr 25, 2022 | GE Healthcare, LLC Field replacement back up batteries distributed on or after April 1, 2019 for Avance CS2, Avance CS2 Pro, Avance, Amingo, Aespire View anesthesia devices Open, Classified |
BSZ | K172045 |
| Apr 25, 2022 | GE Healthcare, LLC Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured
on or after April 1, 2019 Open, Classified |
BSZ | K172045 |
| Apr 21, 2022 | GE Healthcare, LLC GE Healthcare MR Systems, Magnetic Resonance imaging (MRI).
SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery MR750w 3.0T, Discovery MR750 3.0T, SIGNA PET/MR, 1.5T SIGNA Creator, 1.5T SIGNA Open, Classified |
LNH | K211980 |
| Apr 5, 2022 | GE Healthcare, LLC Revolution CT, Revolution CT ES Open, Classified |
JAK | K133705 K163213 +1 |
| Apr 5, 2022 | GE Healthcare, LLC Revolution Apex, Revolution CT with Apex Edition Open, Classified |
JAK | K163213 K191777 |
| Apr 4, 2022 | GE Healthcare, LLC 1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance Imaging System Open, Classified |
LNH | K052293 K121676 |
| Apr 4, 2022 | GE Healthcare, LLC SIGNA Excite 3T. Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
Newest 50 of 793.