Agfa N.V.

Complete recall history across all FDA and CPSC categories — 7 total recalls

Agfa N.V. 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 (7)

FDA medical device enforcement actions by Agfa N.V.

Date Product Reason Class
Jul 29, 2024 DR 800. Digital Radiography X-ray System. Potential for the front lever chain of the DR 800 table to fail. Class II
Feb 23, 2024 Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray ... Steel cable installed inside the mobile column which supports the weight of t... Class II
Apr 6, 2020 AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic, Type numbe... Under specific conditions (Fluoroscopic exam, ABS=OFF, manual change of param... Class II
Feb 10, 2020 AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomograph... Tomosynthesis image acquisition sequence did not stop automatically after exp... Class II
Jun 27, 2019 AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product ... The exposed area of fluo exams possibly does not match the active area of the... Class II
Jan 25, 2019 PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film REF: XJUB8, XJM73, ... Due to an inhomogeneous coating solution, pinholes can become visible in even... Class III
Aug 15, 2018 DX-D 600 Product Usage: The DX-D 600 system is a ceiling mounted General ... A supplier for the Agfa system noted a potential for the steel support cables... Class II

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.

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