Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 ...
FDA Device Recall #Z-2178-2014 — Class III — July 16, 2014
Recall Summary
| Recall Number | Z-2178-2014 |
| Classification | Class III — Low risk |
| Date Initiated | July 16, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | AGFA Healthcare Corp. |
| Location | Greenville, SC |
| Product Type | Devices |
| Quantity | 2617 |
Product Description
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 17; Radiomat B+ NIF 8 x 10; Radiomat B+ NIF 9 1/2 x 9 1/2; CX Ultra UV-G Plus NIF 11 x 14; Radiomat G Plus 14 x 17 NIF Product Usage: Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides of the film, with a radiotransparent material coated on one or both sides of the film, with a photographic emulsion intended to record images during diagnostic radiologic procedures.
Reason for Recall
Some sheets of the medical screen film are fogged.
Distribution Pattern
Worldwide Distribution and US Nationwide in the states of AL, AZ, CA, FL, IL, LA, MI, MN, MS, NE, NH, NJ, NC and country of Canada
Lot / Code Information
Lot Batch No. 79350052, 79380052, 79390074, 79400066, 79410063
Other Recalls from AGFA Healthcare Corp.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0923-2026 | Class II | Brand name: AGFA Digital Radiography X- Ray sys... | Nov 18, 2025 |
| Z-2652-2017 | Class II | IMPAX Cardiovascular The IMPAX CV Reporting mo... | Dec 22, 2016 |
| Z-2735-2017 | Class II | Agfa Healthcare NX 3.0.8950 Imaging Processing ... | 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 ... | Jan 20, 2016 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.