GE Healthcare Japan Corporation FDA Record
- Latest inspection NAI · Dec 15, 2017
- No warning letters matched by name
GE Healthcare Japan Corporation has 4 FDA recalls, 3 inspections, 10 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "GE Healthcare Japan Corporation" is on file.
- Latest recall
- Z-3171-2026 · Jul 31, 2026 · filed under Ge Healthcare
- Latest recall under this name
- Z-2870-2018 · Class II · Apr 27, 2018
- Latest inspection
- Dec 15, 2017 · NAI
- Latest 510(k)
- Mar 23, 2026
Newer recall under related name Ge Healthcare: Jul 31, 2026, Z-3171-2026.
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 4 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 10 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 3 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
GE Healthcare Japan Corporation: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 4 | 0 |
| 2017 | 1 | 0 | 0 | 0 | 0 |
Reviewing GE Healthcare Japan Corporation as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Or check GE Healthcare Japan Corporation yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2870-2018 | Class II | GE Healthcare Revolution EVO, Optima CT660, Optima CT670, Optima CT680. The systems are intended… | Apr 27, 2018 |
| Z-2872-2018 | Class II | GE Healthcare Optima CT540. The systems are intended for head, whole body, cardiac and vascular… | Apr 27, 2018 |
| Z-2873-2018 | Class II | GE Healthcare Optima CT660. The systems are intended for head, whole body, cardiac and vascular… | Apr 27, 2018 |
| Z-2871-2018 | Class II | GE Healthcare Optima CT660. Sold under the following product names: BEIJING OPTIMA CT660 PRO… | Apr 27, 2018 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Dec 15, 2017 | Hino, Japan | Devices | No Action Indicated (NAI) | 3002808529 |
| May 21, 2015 | Hino, Japan | Devices | No Action Indicated (NAI) | 3002808529 |
| Apr 5, 2012 | Hino, Japan | Devices | Voluntary Action Indicated (VAI) | 3002808529 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3002808529 | Hino, Japan | 3 | Dec 15, 2017 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K253686 | True Definition DL | Mar 23, 2026 |
| K233698 | True Enhance DL | Apr 11, 2024 |
| K230807 | Deep Learning Image Reconstruction | Apr 20, 2023 |
| K220961 | Deep Learning Image Reconstruction | Jul 29, 2022 |
| K213938 | Revolution Ascend | Feb 4, 2022 |
| K212067 | Deep Learning Image Reconstruction | Sep 17, 2021 |
| K203169 | Revolution Ascend | Nov 20, 2020 |
| K193170 | Deep Learning Image Reconstruction | Dec 13, 2019 |
| K143345 | SIGNA Pioneer | Jul 10, 2015 |
| K103327 | DISCOVERY MR750W 3.0T | Sep 30, 2011 |
GE Healthcare Japan Corporation and the FDA: common questions
Has GE Healthcare Japan Corporation received an FDA warning letter?
No FDA warning letter addressed to the name "GE Healthcare Japan Corporation" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has GE Healthcare Japan Corporation received an FDA Form 483?
FDA has not published a Form 483 for "GE Healthcare Japan Corporation" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect GE Healthcare Japan Corporation?
The most recent FDA inspection on file ended Dec 15, 2017 at Hino, Japan and was classified NAI. FDA has 3 inspections of GE Healthcare Japan Corporation on file.
Has GE Healthcare Japan Corporation had an FDA recall?
Yes. GE Healthcare Japan Corporation has 4 FDA recalls on record. The most recent under this name started Apr 27, 2018. A newer recall, dated Jul 31, 2026, is filed under the related name Ge Healthcare.
Need more than this page shows? Ask about GE Healthcare Japan Corporation in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.