DKK Dai-Ichi Shomei Co., Ltd. FDA Record
DKK Dai-Ichi Shomei Co., Ltd. has 6 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "DKK Dai-Ichi Shomei Co., Ltd." is on file.
- Latest recall
- Z-2618-2024 · Class II · Jul 9, 2024
- Latest inspection
- Jul 20, 2018 · OAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 6 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 2 | 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
| 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 | 4 | 0 |
| 2023 | 0 | 0 | 0 | 2 | 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 | 1 | 1 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2618-2024 | Class II | Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is… | Jul 9, 2024 |
| Z-2620-2024 | Class II | Aurora 3 Series, Aurora 7 lighthead; Models: AUT7 (including TV models). The Aurora Series is… | Jul 9, 2024 |
| Z-2619-2024 | Class II | Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is… | Jul 9, 2024 |
| Z-2621-2024 | Class II | Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is… | Jul 9, 2024 |
| Z-0071-2024 | Class II | LFS Flat screen arm system with surgical lamp for Models Aurora series, Aurora 2 series, Aurora 3… | Aug 23, 2023 |
| Z-0072-2024 | Class II | LFS Flat screen support arm systems without surgical lamp for models Aurora series, Aurora 2 series… | Aug 23, 2023 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jul 20, 2018 | Itabashi, Japan | Devices | Official Action Indicated (OAI) | 3006437518 |
| May 1, 2014 | Itabashi, Japan | Devices | No Action Indicated (NAI) | 3006437518 |
- 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 3006437518 | Itabashi, Japan | 2 | Jul 20, 2018 |
DKK Dai-Ichi Shomei Co., Ltd. and the FDA: common questions
Has DKK Dai-Ichi Shomei Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "DKK Dai-Ichi Shomei Co., Ltd." 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 DKK Dai-Ichi Shomei Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "DKK Dai-Ichi Shomei Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect DKK Dai-Ichi Shomei Co., Ltd.?
The most recent FDA inspection on file ended Jul 20, 2018 at Itabashi, Japan and was classified OAI. FDA has 2 inspections of DKK Dai-Ichi Shomei Co., Ltd. on file, 1 of them classified OAI (official action indicated).
Has DKK Dai-Ichi Shomei Co., Ltd. had an FDA recall?
Yes. DKK Dai-Ichi Shomei Co., Ltd. has 6 FDA recalls on record. The most recent started Jul 9, 2024.
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