Siemens Healthineers AG FDA Record
- Latest inspection VAI · Jan 26, 2023
- No warning letters matched by name
Siemens Healthineers AG has 0 FDA recalls, 9 inspections, 8 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Siemens Healthineers AG" is on file.
- Latest recall
- Z-3335-2026 · Aug 17, 2026 · filed under Siemens Healthcare Diagnostics
- Latest inspection
- Jan 26, 2023 · VAI
- Latest 510(k)
- Sep 29, 2026
Newer recall under related name Siemens Healthcare Diagnostics: Aug 17, 2026, Z-3335-2026.
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 8 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 9 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Reviewing Siemens Healthineers AG 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 Siemens Healthineers AG yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jan 26, 2023 | Forchheim, Germany | Devices | Voluntary Action Indicated (VAI) | 3004977335 |
| Jul 19, 2016 | Forchheim, Germany | Devices | No Action Indicated (NAI) | 3004977335 |
| Apr 3, 2014 | Forchheim, Germany | Devices | No Action Indicated (NAI) | 3004977335 |
| Sep 21, 2012 | Seongnam, Korea (The Republic Of) | Devices | Voluntary Action Indicated (VAI) | 3005150580 |
| Sep 17, 2012 | Pohang-Si, Korea (The Republic Of) | Devices | Voluntary Action Indicated (VAI) | 3006985147 |
| Jun 3, 2011 | Erlangen, Germany | Devices | No Action Indicated (NAI) | 3002808157 |
| Mar 3, 2011 | Forchheim, Germany | Devices | No Action Indicated (NAI) | 3004977335 |
| May 21, 2009 | Seongnam, Korea (The Republic Of) | Devices | No Action Indicated (NAI) | 3002619337 |
| Dec 3, 2008 | Erlangen, Germany | Devices | No Action Indicated (NAI) | 3002808157 |
- 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 3004977335 | Forchheim, Germany | 4 | Jan 26, 2023 |
| FEI 3005150580 | Seongnam, Korea (The Republic Of) | 1 | Sep 21, 2012 |
| FEI 3006985147 | Pohang-Si, Korea (The Republic Of) | 1 | Sep 17, 2012 |
| FEI 3002808157 | Erlangen, Germany | 2 | Jun 3, 2011 |
| FEI 3002619337 | Seongnam, Korea (The Republic Of) | 1 | May 21, 2009 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K263048 | Syngo Carbon Space (VA4) | Sep 29, 2026 |
| K260852 | MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure | Jul 31, 2026 |
| K253690 | LungMaps | Jun 15, 2026 |
| K253023 | BIOGRAPH One | Jan 15, 2026 |
| K253495 | syngo.MR Applications (VB80) | Nov 20, 2025 |
| K251059 | Syngo Carbon Clinicals (VA41) | Oct 24, 2025 |
| K241898 | Symbia SPECT and SPECT/CT Systems | Jul 26, 2024 |
| K183575 | ACUSON S3000, S2000 Diagnostic Ultrasound System | Mar 20, 2019 |
Siemens Healthineers AG and the FDA: common questions
Has Siemens Healthineers AG received an FDA warning letter?
No FDA warning letter addressed to the name "Siemens Healthineers AG" 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 Siemens Healthineers AG received an FDA Form 483?
FDA has not published a Form 483 for "Siemens Healthineers AG" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Siemens Healthineers AG?
The most recent FDA inspection on file ended Jan 26, 2023 at Forchheim, Germany and was classified VAI. FDA has 9 inspections of Siemens Healthineers AG on file.
Need more than this page shows? Ask about Siemens Healthineers AG 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.