AGFA Healthcare Corp. FDA Record
AGFA Healthcare Corp. has 15 FDA recalls, 8 inspections, 8 510(k) clearances and 2 compliance actions on record. FDA has issued 2 warning letters to AGFA Healthcare Corp., the most recent on Sep 30, 2014.
- Latest recall
- Z-0923-2026 · Class II · Nov 18, 2025
- Latest inspection
- Sep 29, 2016 · VAI
- Latest 510(k)
- Jul 28, 2008
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 15 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 8 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 8 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 2 | 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 | 1 | 0 |
| 2024 | 0 | 0 | 0 | 1 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 1 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 1 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
AGFA Healthcare Corp. FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Sep 30, 2014 | |||
| Apr 15, 2011 |
Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0923-2026 | Class II | Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800 | Nov 18, 2025 |
| Z-0055-2025 | Class II | Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of… | Sep 6, 2024 |
| Z-1004-2023 | Class II | Agfa HealthCare Enterprise Imaging XERO Viewer | Dec 5, 2022 |
| Z-0101-2019 | Class II | Enterprise Imaging Desktops Enterprise Imaging Desktops (Radiology Suite/Cardiology Suite) when… | Aug 3, 2018 |
| Z-2652-2017 | Class II | IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user… | Dec 22, 2016 |
| Z-2735-2017 | Class II | Agfa Healthcare NX 3.0.8950 Imaging Processing Software | Dec 21, 2016 |
| Z-1738-2017 | Class II | DX-D600 - DXD Imaging Package | May 2, 2016 |
| Z-1698-2017 | Class II | AGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated for use in providing diagnostic… | Jan 20, 2016 |
| Z-0283-2016 | Class II | IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX CV 12.x. Corrects… | Sep 1, 2015 |
| Z-2061-2015 | Class II | IMPAX Agility. IMPAX Agility when deployed as a departmental Picture Archiving and communications… | Jun 26, 2015 |
| Z-1745-2015 | Class II | AGFA DX-D 100 is a mobile digital radiography x-ray system | May 29, 2015 |
| Z-0804-2015 | Class III | Radiomat M+ NIF 14 x 17, Radiomat M+ NIF 35CM x 43CM, Radiomat M+ NIF 10 x 12, Radiomat M+ NIF… | Oct 24, 2014 |
| Z-2178-2014 | Class III | Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 x… | Jul 16, 2014 |
| Z-2175-2014 | Class II | DX-D 600 - DXD Imaging Package Product Usage:Is indicated for use in providing diagnostic quality… | Jul 2, 2014 |
| Z-2176-2014 | Class III | Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in providing… | May 13, 2014 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Sep 29, 2016 | Canton, MA | Devices | Voluntary Action Indicated (VAI) | 3000204644 |
| Sep 10, 2015 | Greenville, SC | Devices | No Action Indicated (NAI) | 3001236302 |
| Apr 11, 2014 | Greenville, SC | Devices | Official Action Indicated (OAI) | 3001236302 |
| Mar 29, 2013 | Carlstadt, NJ | Devices | No Action Indicated (NAI) | 1000322596 |
| Nov 4, 2011 | Canton, MA | Devices | Voluntary Action Indicated (VAI) | 3000204644 |
| Jan 6, 2011 | Canton, MA | Devices | Official Action Indicated (OAI) | 3000204644 |
| May 4, 2010 | Carlstadt, NJ | Devices | Voluntary Action Indicated (VAI) | 1000322596 |
| Aug 13, 2009 | Greenville, SC | Devices | No Action Indicated (NAI) | 3001236302 |
- 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.
Compliance Actions
FDA's compliance actions data lists 2 compliance actions under AGFA Healthcare Corp.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3000204644 | Canton, MA | 3 | Sep 29, 2016 |
| FEI 3001236302 | Greenville, SC | 3 | Sep 10, 2015 |
| FEI 1000322596 | Carlstadt, NJ | 2 | Mar 29, 2013 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K081976 | IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION | Jul 28, 2008 |
| K081963 | AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS | Jul 25, 2008 |
| K080013 | REGISTRATION AND FUSION | Jan 17, 2008 |
| K073271 | ORTHOGON | Dec 5, 2007 |
| K072680 | DRYSTAR AXYS, MODEL EYZ4E | Oct 25, 2007 |
| K071972 | ORTHOPEDIC SOFTWARE FOR IMPAX WORKSTATIONS | Jul 30, 2007 |
| K071297 | IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION) | Jun 22, 2007 |
| K071162 | AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS | May 8, 2007 |
AGFA Healthcare Corp. and the FDA: common questions
Has AGFA Healthcare Corp. received an FDA warning letter?
Yes. FDA has issued 2 warning letters to AGFA Healthcare Corp.. The most recent is dated Sep 30, 2014.
Has AGFA Healthcare Corp. received an FDA Form 483?
FDA has not published a Form 483 for "AGFA Healthcare Corp." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect AGFA Healthcare Corp.?
The most recent FDA inspection on file ended Sep 29, 2016 at Canton, MA and was classified VAI. FDA has 8 inspections of AGFA Healthcare Corp. on file, 2 of them classified OAI (official action indicated).
Has AGFA Healthcare Corp. had an FDA recall?
Yes. AGFA Healthcare Corp. has 15 FDA recalls on record. The most recent started Nov 18, 2025.
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