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Medical device manufacturer

GE Healthcare GmbH

GE Healthcare GmbH holds 169 FDA 510(k) clearances across 35 product codes. Median elapsed review time is 56 days. openFDA lists 787 recall records naming the company. FDA publishes it under 15 different spellings, all counted here as one company.

Updated · ingest status · JSON

510(k) clearances
169
Product codes
35
Median review
56 days
Recall records
787

How does FDA spell GE Healthcare GmbH?

FDA publishes this company under 15 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.

Every spelling FDA published for this company, and which dataset each came from.
As FDA published itDatasetMatched by
GE HEALTHCAREdevice/registrationlistingnormalised
GE Healthcaredevice/enforcementnormalised
GE Healthcaredevice/recallnormalised
GE Healthcaredevice/510knormalised
GE Healthcare GmbHdevice/enforcementnormalised
GE Healthcare GmbHdevice/recallnormalised
GE Healthcare GmbHdevice/registrationlistingnormalised
GE Healthcare LLCdevice/enforcementnormalised

Showing 8 of 15.

Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.

Which product codes does GE Healthcare GmbH file in?

35 product codes, ranked by how much they file in each.

Product codes this company holds clearances in, with their median elapsed review time in each.
CodeDeviceClearancesMedian reviewLatest
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic5255 days
LLZSystem, Image Processing, Radiological2381 days
KPSSystem, Tomography, Computed, Emission1221 days
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)1069 days
MUEFull Field Digital, System, X-Ray, Mammographic987 days
JAKSystem, X-Ray, Tomography, Computed717 days
LNHSystem, Nuclear Magnetic Resonance Imaging549 days
MSXSystem, Network And Communication, Physiological Monitors529 days
OWBInterventional Fluoroscopic X-Ray System554 days
DQKComputer, Diagnostic, Programmable481 days
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase324 days
FLLContinuous Measurement Thermometer371 days
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)399 days
OLWIndex-Generating Electroencephalograph Software335 days
GXYElectrode, Cutaneous287 days
ITXTransducer, Ultrasonic, Diagnostic211 days
IZISystem, X-Ray, Angiographic263 days
MOSCoil, Magnetic Resonance, Specialty229 days
CCLAnalyzer, Gas, Oxygen, Gaseous-Phase127 days
DQAOximeter113 days
DSIDetector And Alarm, Arrhythmia1315 days
DXJDisplay, Cathode-Ray Tube, Medical156 days
EYCCatheter, Upper Urinary Tract143 days
FMTWarmer, Infant Radiant1241 days
FMZIncubator, Neonatal181 days

Showing the 25 they file in most, of 35.

Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.

Source: openFDA device/510k · retrieved

Has GE Healthcare GmbH had a recall?

openFDA lists 787 recall records naming this company across its whole history, of which 3 were opened in the last 12 months and are not yet marked terminated. A recall record covers one firm's corrective action and may span many device lots.

  • Z-1767-2026Class IIOpen, ClassifiedLNH

    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.

  • Z-1475-2026Class IIOpen, ClassifiedLLZ

    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,

  • Z-0935-2026Class IIOpen, ClassifiedLLZ

    GE HealthCare has become aware that the Patient History tab in ViewPoint 6 versions 6.15.3 and 6.15.4 ultrasound software may not include complete patient medical history information.

  • Z-1483-2025Class IIOpen, ClassifiedLLZ

    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.

  • Z-1484-2025Class IIOpen, ClassifiedLLZ

    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.

Showing the 5 most recently initiated of 787.

Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.

Source: openFDA device/recall · retrieved

What has GE Healthcare GmbH cleared recently?

Most recent 510(k) clearances for this company, newest first.
510(k)DeviceCodeDecisionElapsed days
K253639ViewLLZ50
K242925MR Contour DLQKB189
K241300ViewPoint 6LLZ54
K232346Digital Expert Access with Remote ScanningLNH84
K223212Precision DLKPS192
K221680Xeleris V Processing and Review SystemLLZ265
K221932Omni LegendKPS63
K213689Voluson P6, Voluson P8IYN86
K213642Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 ExpertIYN56
K211488LOGIQ E10IYN120

Source: openFDA device/510k · retrieved

Where is GE Healthcare GmbH registered?

FDA lists 2 registered establishments for this company in US.

Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.

Watch what GE Healthcare GmbH files next

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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.