Recall Register

GE Healthcare: FDA recalls

FDA enforcement events from 2013 to 2026; export dated . The recall start date and FDA report date are separate fields. Read the recall classes.

FDA enforcement reports name GE Healthcare as the recalling firm in 44 events. The events have 95 product records. The recalls started from 2013 to 2026. All the events are device recalls. By FDA enforcement events, GE Healthcare is number 75 of 1,628 firms that have a page. Events that GE Healthcare started: 4 in 2024 and 1 in 2025. For all FDA enforcement events, the count rose by 3.6%, from 1,773 in 2024 to 1,836 in 2025. Class II is 97.7% of its events and 73.7% of all FDA events.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

44 events, newest first.

FDA enforcement events of GE Healthcare
InitiatedProduct (first record)TypeClassRecordsStatus
31 Jul 2026Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical data, All VersionsDeviceClass II6Ongoing
16 Jan 2026GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047; System, Image Processing, RadiologicalDeviceClass II1Ongoing
19 Feb 2025GE 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)…DeviceClass II5Ongoing
3 Oct 2024GE 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 /…DeviceClass II1Ongoing
29 Aug 2024GE 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) …DeviceClass II1Ongoing
5 Aug 2024GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.DeviceClass II1Ongoing
23 Jul 2024GE 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 systemDeviceClass II1Ongoing
14 Sep 2023Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiological Image Processing SystemDeviceClass II3Ongoing
8 Sep 2023Centricity Universal Viewer Workflow Manager, Image processing radiological systemDeviceClass II2Ongoing
28 Mar 2023Centricity 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 Processing SystemDeviceClass II3Ongoing
8 May 2020The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical-care and emergency room…DeviceClass II1Ongoing
23 Feb 2018GE Healthcare Centricity PACS-IW, Model Numbers: (a) 2052831-00X (b) 2049588-008 Product Usage: Centricity PACS-IW by GE Healthcare is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the…DeviceClass II1Terminated
25 Jan 2018Centricity PACS-IW with Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer…DeviceClass II2Terminated
28 Sep 2015The Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Typical users of this system…DeviceClass II2Terminated
16 Sep 2015Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.DeviceClass II1Terminated
31 Aug 2015GE Healthcare, Discovery MR750w 3.0T. Product Usage: The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T Systems are whole body magnetic resonance scanners for diagnostic imaging.DeviceClass II7Terminated
11 Aug 2015Centricity PACS-IW with Universal Viewer Product Usage: The Centricity PACS-IW with Universal Viewer is a picture archiving and communications system, a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Its hardware…DeviceClass II2Terminated
17 Jul 2015Lightspeed 16 CTDeviceClass II3Terminated
10 Jul 2015GE Healthcare, Signa Infinity MR System; Signa MR/i MR System; SmartSpeed; EchoSpeed Plus; HighSpeed Plus, Signa Infinity MR System with EXCITE Technology, Excite II, Signa 3T Infinity with Excite, Signa Excite 1.5T and Signa Excite 3T, Signa Excite HD, Signa HD 1.5T and Signa HD 3.0T, Signa HDx, Signa HDxt, Signa…DeviceClass II1Terminated
12 Jun 2015GE Healthcare Precision 500D Classical R & F system.DeviceClass II4Terminated
12 Jun 2015GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic Systems. A universal diagnostic imaging system for radiographic and fluoroscopic examinations. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Legacy and Legacy D Table is…DeviceClass II1Terminated
29 May 2015GE Healthcare Optima IGS 320. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.DeviceClass II13Terminated
4 May 2015GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50).DeviceClass II1Terminated
24 Apr 2015D-fend, (p/n 876446-HEL), and D-fend+ (p/n 881319-HEL) water trap. Used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 monitors. Product Usage: Water traps are intended to protect the GE monitor from humidity, secretions and bacterial contamination when monitoring respiratory parameters. D-fend and…DeviceClass II1Terminated
22 Apr 2015CT LightSpeed 16 and Discovery ST Pet/CT DST. Catalogue # 2339985. Designed to be a head and whole body CT scanner utilizing a new solid state detector.DeviceClass II1Terminated
12 Mar 2015GE Healthcare, Treadmill T2100. For Exercise Testing, facilitating accurate blood pressure measurements and exercise testing within speed range of 0-13.5 miles per hour.DeviceClass II1Terminated
9 Mar 2015Kenex Radiation Shield installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems.DeviceClass II1Terminated
9 Mar 2015GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T WITH EXCITE, SIGNA EXCITE 1.5T, SIGNA EXCITE 3.0T, GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T, SIGNA Contour, Brivo MR355, Optima…DeviceClass II1Terminated
5 Mar 2015GE Healthcare Millennium VG, Discovery VH and VariCam Nuclear Medicine systems, all configurations. Product Usage: The intended use of the system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by…DeviceClass II1Terminated
27 Feb 2015GE Healthcare, Aespire 7900, Aespire View Anesthesia Machines. Model numbers 1009-9012-000. Intended to provide general inhalation anesthesia and ventilatory support to a wide range of patientsDeviceClass II1Terminated
16 Feb 2015GE Healthcare, Treadmill T2100 and Treadmill T2000 with power cord part numbers 408930-001 Rev E, 408930-002 Rev C, or 2028038-008 Rev B. Also Field Replaceable Unit P/N’s 408930-001 Rev E, 408930-002 Rev C. UPDATE: 3-30-2015: T2100 & T2000 Treadmills with power cord part numbers 408930-001, 408930-002, or…DeviceClass II1Terminated
30 Jan 2015GE Healthcare Proteus XR/a with wall stand model number 2260354. Intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.DeviceClass II1Terminated
27 Jan 2015GE Healthcare Engstrom Carestation, Engstrom Pro, Cart Only S/5 EC. GE model numbers 1505-8538-000, 1505-9000-000, and 1505-9003-000. Ventilators.DeviceClass II1Terminated
7 Jan 2015This correction applies to all GE Healthcare MRI systems with superconducting magnets: Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, GE 1.5T Signa HDe, Optima MR360, Brivo MR355, Signa Excite-HD 1.5T & 3T, Signa Excite 1.5T HD Twinspeed, Signa Excite 1.5T HD Echospeed, Signa Excite 1.5T HD…DeviceClass I1Terminated
19 Dec 2014GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner.DeviceClass II1Terminated
19 Dec 2014GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amxDeviceClass II3Terminated
10 Dec 2014GE Healthcare, Discovery IGS 730 & Discovery IGS 740. Discovery IGS 730 : The angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular & non vascular diagnostic and interventional procedures. Discovery IGS 740: The angiographic…DeviceClass II1Terminated
8 Dec 2014GE Healthcare, Proteus XR/a with wall stand model number 600-0301.DeviceClass II1Terminated
12 Nov 2014The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient table, scanner desktop (operator console), system cabinet, power distribution unit (POU). and interconnecting cables.The system includes image acquisition hardware, image acquisition and reconstruction software, and…DeviceClass II1Terminated
24 Oct 2014GE Discovery MR950 MRI systemDeviceClass II1Terminated
3 Apr 2014The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professional, including radiologists, physicians, technologists, clinicians, and nurses. It is also intended for use as a clinical review workstation throughout the healthcare…DeviceClass II1Terminated
2 Apr 2014Giraffe Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate…DeviceClass II5Terminated
12 Dec 2013Giraffe Infant Warmers, part number M1118179, labeled in part *** GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com* Giraffe Infant Warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology.DeviceClass II6Terminated
18 Feb 2013The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare…DeviceClass II1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

GE Healthcare: events for each product type
TypeEvents
Device44
GE Healthcare: events in each class
ClassEvents
Class II43
Class I1
Share of the events of the firm in Class I
2%
Share of all events on the register in Class I
18%
Events with the status Ongoing
11

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of GE Healthcare, by the year that the recall started. The largest year is 2015, with 21 events.

Official channels

Cite this page

Recall Register. GE Healthcare: FDA recalls. https://recallregister.com/firm/ge-healthcare/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
3 Nov 2026
State of the firm address
WI, IL

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not rate one firm against another. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of GE Healthcare have?
Class II: 43 events. Class I: 1 event. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of GE Healthcare?
FDA event 99661, which the firm started on 31 Jul 2026. The first product in the record is: Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical data, All Versions
How many FDA recalls of GE Healthcare have the status Ongoing?
11 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.