G.E. Healthcare

FDA Regulatory Profile

G.E. Healthcare has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Mar 3, 2010 · NAI

Newer recall under related name Ge Healthcare: Jul 31, 2026, Z-3171-2026.

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances0Oct 4, 2026Not statedCurrent
Inspections1Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Related names

NameRecalls510(k)InspectionsComplianceMost recent recall
Bk Medical Aps
subsidiary / division
0900—
B-K Medical Aps
subsidiary / division
01100—
Caption Health
subsidiary / division
1610May 19, 2021 (Z-2111-2021)
Datex-Ohmeda
subsidiary / division
239960Jul 30, 2026 (Z-3192-2026)
Datex--Ohmeda
subsidiary / division
7000Sep 3, 2024 (Z-0048-2025)
Ge Healthcare Finland
subsidiary / division
223220Sep 26, 2025 (Z-0457-2026)
Ge Medical Systems
subsidiary / division
168329110Jun 5, 2026 (Z-2728-2026)
Ge Medical Systems Information Technologies
subsidiary / division
2017170Jul 30, 2026 (Z-3143-2026)
Ge Medical Systems, Israel
subsidiary / division
1000Sep 6, 2023 (Z-2652-2023)
Ge Medical Systems Israel
subsidiary / division
0200—
Ge Medical Systems Ultrasound And Primary Care Diagnostics
subsidiary / division
08310—
Ge Vingmed Ultrasound
subsidiary / division
61100May 2, 2024 (Z-2317-2024)

Recent FDA Inspections

DateSiteProductClassificationFEI
Mar 3, 2010South San Francisco, CADevicesNo Action Indicated (NAI)2936804

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.