Pediatric X-ray Imaging
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with the product. If you suspect a problem with a medical imaging device, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting Program .
Medical device manufacturers, distributors, importers and device user facilities (which include many health care facilities) must comply with FDA’s Medical Device Reporting (MDR) Regulations at 21 CFR Part 803 .
Health care personnel employed by facilities that are subject to FDA's device user facility reporting requirements  should follow the reporting procedures established by their facilities.