What must be labeled on mobile unit C-arm fluoroscopic systems manufactured after June 10, 2006?

Mobile unit C-arm fluoroscopic systems manufactured after June 10, 2006, must be labeled as "For extremity use only" to comply with safety regulations and standards set by the FDA and other regulatory bodies. This labeling is crucial because it addresses the specific use of the device, indicating that it has been designed and validated to perform fluoroscopic imaging of extremities safely. Understanding this limitation helps healthcare professionals ensure that they are using the equipment appropriately, reducing the risk of exposure to unnecessary radiation and preventing misuse in areas of the body for which the device was not designed.

The focus on extremity use also reflects concerns about patient safety, including potential radiation dose exposure and the unique anatomical and physiological considerations when imaging different parts of the body. Mislabeling could lead to significant risks or complications if the equipment were used inappropriately for procedures outside its intended scope.