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GE Healthcare

United States·US-MF-000001862

Last updated September 17, 2026

Information

Country
United States
Address
500, W Monroe Street, Chicago, United States
LinkedIn
—
Facebook
—
Phone
+1(800)437-1171
PRRC Contact
Elizabeth Mathew
EUDAMED SRN
US-MF-000001862
FDA FEI Number
3004526608
DUNS Number
054324257

Catalogue (168)

Page 1 of 4
DeviceModel / ReferenceRegistriesClassStatus
Logiq E K133533
FDA 510(k)
Class IIActive
MyoSPECT, MyoSpect ES K212004
FDA 510(k)
Class IIActive
Digital Expert Access 1
FDA UDI
Class IIActive
ViewPoint 6 ver6.8
FDA UDI
Class IIUnknown
Centricity CPACS 7.0
FDA UDI
Class IIActive
ViewPoint ver5.6
FDA UDI
Class IIUnknown
ViewPoint 6. ver11
FDA UDI
Class IIUnknown
Centricity CPACS RA1000 6.0
FDA UDI
Class IIActive
Centricity Perinatal6.97
FDA UDI
Class IIUnknown
Centricity PERINATAL6.96
FDA UDI
Class IIUnknown
SenoIris 1
FDA UDI
Class IIUnknown
ViewPoint 6 ver 6.7
FDA UDI
Class IIUnknown
Centricity CPACS 4.0
FDA UDI
Class IIActive
ViewPoint 6. ver6.9
FDA UDI
Class IIUnknown
Senolris 1
FDA UDI
Class IIUnknown
Graffiti NotifyMe V1.0
FDA UDI
Class IIUnknown
ViewPoint 6. ver12
FDA UDI
Class IIActive
ViewPoint 6. ver10
FDA UDI
Class IIUnknown
Centricity PACS - RA1000 v7.0 5831882-x
EUDAMEDFDA UDI
Class IIaActive
Centricity Enterprise Web 3.0 2027870-x
EUDAMED
Class IActive
Universal Viewer 8.1 5865733-001
EUDAMEDFDA UDI
Class IIaActive
Senographe Pristina K163302
FDA 510(k)
Class IIActive
Datex-Ohmeda S/5 Eeg Module, E-Eeg And Datex-Ohmeda S/5 Eeg Headbox, N-Eeg And Accessories. K051883
FDA 510(k)
Class IIActive
Integradweb Pacs System K072986
FDA 510(k)
Class IIActive
Ge Logiq P6/P6 Pro K101874
FDA 510(k)
Class IIActive
Voluson E6/E8/E8 Expert Diagnostic Ultrasound System Model: H48681bd/ H48681bx/ H48681bm K101236
FDA 510(k)
Class IIActive
Voluson E6, Voluson E8, Voluson E10 K181985
FDA 510(k)
Class IIActive
Revolution Xr/D Digital Radiographic Imaging System With Tomosynthesis K051967
FDA 510(k)
Class IIActive
Mac-Lab/Cardiolab /combolab/Specialslab System K061741
FDA 510(k)
Class IIActive
Logiq S8 K170445
FDA 510(k)
Class IIActive
Pristina Serena 3D K182951
FDA 510(k)
Class IIActive
Unity Network ID K170199
FDA 510(k)
Class IIActive
Discovery NM 750b Bopsy K160933
FDA 510(k)
Class IActive
Advantage Workstation 4.3. K052995
FDA 510(k)
Class IIActive
Precision DL K223212
FDA 510(k)
Class IIActive
Datex-Ohmeda S/5 Anesthesia Monitor With L-Aneo5 And L-Aneo5a Software, Using F-Cu8 Or F-Cu5(p) Monitor Frame Options K051400
FDA 510(k)
Class IIActive
Ge Vantage Pet Neuro Software K062393
FDA 510(k)
Class IIActive
Innova 2100-Iq, Innova 3100, Innova 3100-Iq, Innova 4100, And Innova 4100-Iq K052412
FDA 510(k)
Class IIActive
Logiq E9 K110943
FDA 510(k)
Class IIActive
Ge Innova Solid State Xray Imager Flurosopic X Ray System K113034
FDA 510(k)
Class IIActive
Datex-Ohmeda S/5 Bis Module, E-Bis And Accessories K052145
FDA 510(k)
Class IIActive
Logiq E9 Diagnostic Ultrasound System K123564
FDA 510(k)
Class IIActive
Brivo Nm 615 K113350
FDA 510(k)
Class IIActive
Tram Module K053121
FDA 510(k)
Class IIActive
Innova Epvision 2.0, Innova Epvision 2.0 K130069
FDA 510(k)
Class IIActive
Logiq E9 Diagnostic Ultrasound System K142160
FDA 510(k)
Class IIActive
Datex-Ohmeda S/5 Neuromuscular Transmission Module, E-Nmt And Accessories K051635
FDA 510(k)
Class IIActive
Datex-Ohmeda S/5 Critical Care Monitor With L-Icu05 And L-Icu05a Software K071889
FDA 510(k)
Class IIActive
Discovery NM/CT 670 CZT K153402
FDA 510(k)
Class IIActive
Unity Network ID K183116
FDA 510(k)
Class IIActive

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FDA Recalls (100)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
Feb 27, 2026Z-1767-2026—open, classified

Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/serviced with ferrous (steel) fittings instead of non-ferrous (brass) fittings on the magnet rear and if system is accessed to perform service while the magnet is ramped, the magnetic field could attract the ferrous fittings potentially resulting in personnel injury.

Jan 16, 2026Z-1475-2026—open, classified

Under certain workflows, patient information shown in the viewer may not match the images displayed on Centricity Universal Viewer Zero Footprint Client (ZFP) with versions ZFP v6.0: SP11.6, SP11.6.0.1 and SP11.6.1 on systems with Patient Timeline installed,

Feb 19, 2025Z-1487-2025—open, classified

There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.

Feb 19, 2025Z-1486-2025—open, classified

There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.

Feb 19, 2025Z-1485-2025—open, classified

There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.

Feb 19, 2025Z-1484-2025—open, classified

There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.

Feb 19, 2025Z-1483-2025—open, classified

There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.

Oct 3, 2024Z-0318-2025—open, classified

GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (ZFP) where there is a potential security vulnerability which could allow a malicious actor to access the system and potentially manipulate patient data.

Aug 29, 2024Z-0039-2025—open, classified

GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (ZFP) version v6.0 SP11.x where the latest report is not shown by default to the user. The issue may occur when a study has multiple DICOM structured reports (i.e. preliminary, final, and/or addendum) stored in different series.

Aug 5, 2024Z-3214-2024—open, classified

GE HealthCare has become aware of an issue where image storage is not possible when Centricity PACS reaches the maximum number of unique image identifiers (Ckeys). If this occurs, it can result in acquisition of a partial study.

Jul 23, 2024Z-3160-2024—open, classified

Footprint Client (ZFP) versions v6.0 SP9.x and SP10.x where the latest addended report is not shown by default to the user. The issue occurs when the addendum is created on the same day as the original report but at a different time, and only when launched on the following browsers. " Internet Explorer 10 (IE10) " Internet Explorer 11 (IE11) " Firefox.

Sep 14, 2023Z-0140-2024—open, classified

GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-IW with Universal Viewer V5.0 and Centricity Universal Viewer V6.0 with PACS-IW foundation.

Sep 14, 2023Z-0139-2024—open, classified

GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-IW with Universal Viewer V5.0 and Centricity Universal Viewer V6.0 with PACS-IW foundation.

Sep 14, 2023Z-0138-2024—open, classified

GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-IW with Universal Viewer V5.0 and Centricity Universal Viewer V6.0 with PACS-IW foundation.

Sep 8, 2023Z-0142-2024—open, classified

When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a third-party reporting application is used to launch exams, it could display information on a different patient than WFM and the Viewer.

Sep 8, 2023Z-0143-2024—open, classified

When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a third-party reporting application is used to launch exams, it could display information on a different patient than WFM and the Viewer.

Mar 28, 2023Z-1501-2023—open, classified

GE HealthCare has become aware of an issue where information from two different patients can be mismatched when correcting patient or study information.

Mar 28, 2023Z-1500-2023—open, classified

GE HealthCare has become aware of an issue where information from two different patients can be mismatched when correcting patient or study information.

Mar 28, 2023Z-1502-2023—open, classified

GE HealthCare has become aware of an issue where information from two different patients can be mismatched when correcting patient or study information.

Jul 15, 2022Z-1566-2022—open, classified

Inaccurate Distance and Area measurements with use of Global Stack viewport.

Jun 24, 2022Z-1430-2022—open, classified

Under rare conditions, SIGNA Premier gradient coils could result in elevated acoustic noise during scanning. After prolonged periods of elevated acoustic noise, this could potentially lead to hearing loss.

Jun 14, 2022Z-1466-2022—terminated

The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams.

Jun 8, 2022Z-1333-2022—open, classified

Potential to display inaccurate measurements on images in Centricity Universal Viewer Zero Footprint Client (ZFP)

Jun 2, 2022Z-1511-2022—open, classified

As a result of unclear guidance in the service manual, the table can drop during a specific service activity if the wrong screws are removed by the service personnel without the appropriate table supports in place resulting in injury to service personnel.

Jun 1, 2022Z-1389-2022—terminated

There is a potential reversal of the O2 and air cylinder pressure transducer connections.

May 27, 2022Z-1427-2022—open, classified

The base of the anesthesia system can have a crack and could potentially fracture resulting in a tip or overbalance of the anesthesia system. This can result in potential injury if it falls on a person.

May 10, 2022Z-1265-2022—open, classified

The CARESAPE Central Station (CSCS) V2 can shut down due to a potential power supply component failure. This can lead to loss of patient monitoring at the central station.

Apr 28, 2022Z-1233-2022—open, classified

Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.

Apr 28, 2022Z-1229-2022—open, classified

Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.

Apr 28, 2022Z-1231-2022—open, classified

Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.

Apr 28, 2022Z-1230-2022—open, classified

Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.

Apr 28, 2022Z-1232-2022—open, classified

Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.

Apr 25, 2022Z-1286-2022—open, classified

Backup batteries can fail earlier than their estimated life.

Apr 25, 2022Z-1285-2022—open, classified

Backup batteries can fail earlier than their estimated life.

Apr 18, 2022Z-1227-2022—open, classified

Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.

Apr 18, 2022Z-1226-2022—open, classified

Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.

Mar 16, 2022Z-0919-2022—completed

Two scenarios may cause edits to measurements and diagnosis statements can be lost after a test is Signed in the MUSE NX web client.

Mar 4, 2022Z-0983-2022—open, classified

During the de-installation of an MR system magnet, if all rigging and hardware that attach to the magnet for transportation are not properly installed and secured, the magnet may fall, leading to potential injury.

Feb 18, 2022Z-0859-2022—open, classified

There is potential for the images to be flipped left to right.

Feb 18, 2022Z-0857-2022—open, classified

There is potential for the images to be flipped left to right.

Feb 18, 2022Z-0860-2022—open, classified

There is potential for the images to be flipped left to right.

Feb 18, 2022Z-0858-2022—open, classified

There is potential for the images to be flipped left to right.

Jan 28, 2022Z-0808-2022—open, classified

If the CARESCAPE Central Station v2.0 is used with an unapproved keyboard, the audio can be muted resulting in loss of audible alarms.

Dec 23, 2021Z-0594-2022—open, classified

The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

Dec 23, 2021Z-0607-2022—open, classified

The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

Dec 23, 2021Z-0606-2022—open, classified

The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

Dec 23, 2021Z-0608-2022—open, classified

The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

Dec 23, 2021Z-0609-2022—open, classified

The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

Dec 23, 2021Z-0590-2022—open, classified

The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

Dec 23, 2021Z-0595-2022—open, classified

The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

Dec 23, 2021Z-0616-2022—open, classified

The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

Dec 23, 2021Z-0611-2022—open, classified

The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

Dec 23, 2021Z-0617-2022—open, classified

The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

Dec 23, 2021Z-0614-2022—open, classified

The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

Dec 23, 2021Z-0601-2022—open, classified

The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

Dec 23, 2021Z-0593-2022—open, classified

The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

Dec 23, 2021Z-0592-2022—open, classified

The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

Dec 23, 2021Z-0602-2022—open, classified

The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

Dec 23, 2021Z-0603-2022—open, classified

The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

Dec 23, 2021Z-0610-2022—open, classified

The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

Dec 23, 2021Z-0598-2022—open, classified

The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

Dec 23, 2021Z-0613-2022—open, classified

The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

Dec 23, 2021Z-0605-2022—open, classified

The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

Dec 23, 2021Z-0618-2022—open, classified

The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

Dec 23, 2021Z-0600-2022—open, classified

The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

Dec 23, 2021Z-0597-2022—open, classified

The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

Dec 23, 2021Z-0619-2022—open, classified

The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

Dec 23, 2021Z-0591-2022—open, classified

The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

Dec 23, 2021Z-0596-2022—open, classified

The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

Dec 23, 2021Z-0615-2022—open, classified

The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

Dec 23, 2021Z-0604-2022—open, classified

The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

Dec 23, 2021Z-0612-2022—open, classified

The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

Dec 23, 2021Z-0620-2022—open, classified

The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

Dec 23, 2021Z-0621-2022—open, classified

The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

Dec 23, 2021Z-0599-2022—open, classified

The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

Nov 4, 2021Z-0521-2022—open, classified

The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.

Nov 4, 2021Z-0524-2022—open, classified

The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.

Nov 4, 2021Z-0523-2022—open, classified

The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.

Nov 4, 2021Z-0518-2022—open, classified

The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.

Nov 4, 2021Z-0522-2022—open, classified

The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.

Nov 4, 2021Z-0520-2022—open, classified

The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.

Nov 4, 2021Z-0519-2022—open, classified

The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.

Oct 15, 2021Z-0329-2022—open, classified

There is a potential to display incomplete patient imaging study.

Aug 26, 2021Z-0132-2022—completed

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

Aug 26, 2021Z-0139-2022—completed

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

Aug 26, 2021Z-0135-2022—completed

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

Aug 26, 2021Z-0138-2022—completed

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

Aug 26, 2021Z-0133-2022—completed

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

Aug 26, 2021Z-0137-2022—completed

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

Aug 26, 2021Z-0140-2022—completed

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

Aug 26, 2021Z-0141-2022—completed

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

Aug 26, 2021Z-0134-2022—completed

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

Aug 26, 2021Z-0136-2022—completed

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

Aug 12, 2021Z-0012-2022—terminated

A software anomaly exists in the Centricity Universal Viewer study management feature in which study changes are not propagated to either the Centricity Enterprise Archive (EA) or another Vendor Neutral Archive (VNA).

Aug 6, 2021Z-2502-2021—open, classified

Image acquisition failures and synchronization failure with the Centricity Enterprise Archive

Aug 6, 2021Z-2503-2021—open, classified

Image acquisition failures and synchronization failure with the Centricity Enterprise Archive

Aug 2, 2021Z-2595-2021—open, classified

The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts that could cause leaks resulting in incorrect anesthesia machine tidal volumes potentially leading to over-delivery of volume to the patient.

Aug 2, 2021Z-2596-2021—open, classified

The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts that could cause leaks resulting in incorrect anesthesia machine tidal volumes potentially leading to over-delivery of volume to the patient.

Jun 30, 2021Z-2022-2021—open, classified

When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a space or the user interface will not update to confirm the intended group(s) has been added to the acquisition.

Jun 30, 2021Z-2023-2021—open, classified

When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a space or the user interface will not update to confirm the intended group(s) has been added to the acquisition.