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AGFA Healthcare Corp.

Complete recall history across all FDA and CPSC categories — 12 total recalls

AGFA Healthcare Corp. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (12)

FDA medical device enforcement actions by AGFA Healthcare Corp.

Date Product Reason Class
Nov 18, 2025 Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic... It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/mi... Class II
Dec 22, 2016 IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database an... A customer experienced when using IMPAX CV Reporting software, specifically, ... Class II
Dec 21, 2016 Agfa Healthcare NX 3.0.8950 Imaging Processing Software A customer reported that when using an NX workstation with software version N... Class II
May 2, 2016 DX-D600 - DXD Imaging Package One of the dent markers from the DX-D600 dropped down from the overhead rail. Class II
Jan 20, 2016 AGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated for use i... The DX-D100 User Manual already contained information about to move a DX-D100... Class II
Sep 1, 2015 IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IM... Customers have experienced IMPAX CV software, specifically, Demographics Mana... Class II
Jun 26, 2015 IMPAX Agility. IMPAX Agility when deployed as a departmental Picture Archi... Firm received a complaint that the hospital had sent two accession numbers ov... Class II
May 29, 2015 AGFA DX-D 100 is a mobile digital radiography x-ray system When using the DX-D 100 unit, sporadic unintended movements caused by an elec... Class II
Oct 24, 2014 Radiomat M+ NIF 14 x 17, Radiomat M+ NIF 35CM x 43CM, Radiomat M+ NIF 10 x 12... Some material of the coating Type CXCPMV3 has potential artifacts showing a s... Class III
Jul 16, 2014 Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355;... Some sheets of the medical screen film are fogged. Class III
Jul 2, 2014 DX-D 600 - DXD Imaging Package Product Usage:Is indicated for use in provi... Some customers reported that while using the DX-D600 in room or exam preparat... Class II
May 13, 2014 Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicate... Unit was mislabeled with a factory label showing 32 KW output power. Class III

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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