AGFA Corp.
Complete recall history across all FDA and CPSC categories — 11 total recalls
AGFA 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 (11)
FDA medical device enforcement actions by AGFA Corp.
| Date | Product | Reason | Class |
|---|---|---|---|
| Jun 6, 2014 | AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 is indicate... | When liquid comes in contact with the DX-D 100 touch screen, the device may i... | Class II |
| Apr 30, 2014 | IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optic... | Failure to effectively install and test a hotfix to correct the known softwar... | Class II |
| Jan 8, 2014 | IMPAX RIS QDOC 5.8 | Patient name displayed (printed) on the Patient Report was the wrong patient... | Class II |
| Sep 19, 2013 | IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Arch... | System downtime and/or slow performance may result if software in use is an o... | Class II |
| May 15, 2013 | AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicate... | Customers could potentially experience intermittent, unintended and illogical... | Class II |
| Mar 15, 2013 | IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Repor... | Baseline pulmonary capillary wedge (PCW) pressure values from IMPAX CV Report... | Class II |
| Mar 15, 2013 | IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitat... | Software design error in IMPAX CV 7.8 SU3 | Class II |
| Feb 7, 2013 | CR MD1.0 General Set, x-ray imager image plate. CR 10-X Image Plate 35CM X 4... | The cassettes were shipped with the wrong IP (image plate) size bar code. | Class II |
| Aug 9, 2012 | AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMSt... | Loss of patient data can occur under certain circumstances due to misconfigur... | Class II |
| Jul 27, 2012 | IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured rep... | Content entered into the "Conclusions" free text box on the Report Writer scr... | Class II |
| Jul 10, 2012 | IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting componen... | When users selected "Left stenosis" in the "Graft Duplex Conclusion" section ... | 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.
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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