Caption Health
FDA Regulatory Profile
Caption Health has 1 FDA recall, 1 inspection, 6 510(k) clearances and 0 compliance actions on record.
- Latest recall
- Z-2111-2021 · Class II · May 19, 2021
- Latest inspection
- Sep 30, 2021 · NAI
- Latest 510(k)
- Jan 15, 2025
Newer recall under related name Ge Healthcare: Jul 31, 2026, Z-3171-2026.
Part of the Ge Healthcare corporate family.
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 1 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 6 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 1 | Nov 8, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Related names
| Name | Recalls | 510(k) | Inspections | Compliance | Most recent recall |
|---|
Ge Healthcare
parent company | 573 | 169 | 37 | 0 | Jul 31, 2026 (Z-3171-2026) |
G.E. Healthcare
parent company | 0 | 0 | 1 | 0 | — |
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2111-2021 | Class II | Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application… | May 19, 2021 |
Recent FDA Inspections
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.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3016665037 | Brisbane, CA | 1 | Sep 30, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K243065 | Cardiac Guidance | Jan 15, 2025 |
| DEN220063 | Caption Interpretation Automated Ejection Fraction Software | Feb 24, 2023 |
| K210747 | Caption Interpretation Automated Ejection Fraction Software | Jan 19, 2022 |
| K201992 | Caption Guidance | Sep 18, 2020 |
| K200621 | Caption Interpretation Automated Ejection Fraction Software | Jul 22, 2020 |
| K200755 | Caption Guidance | Apr 16, 2020 |