Radiology device recalls significantly increased from 2003 to 2012, according to the Medical Device Recall Report that was published by the Food and Drug Administration (FDA) on March 21.
Many of the radiology device recalls have been attributed to the reduction of unnecessary radiation exposure, said the FDA. “Radiology device recalls increased in 2010 following enhanced media and FDA attention, relating to concerns aimed at reduction of unnecessary radiation exposure,” wrote the report’s authors.
The rise in the annual number of recalls seen during the study period is also due in part to increased reporting of recalls by radiological device firms, according to the report. Recalls and risks were seen from imaging and therapy radiology devices that include linear accelerators, image processing systems, and computed tomography.
Statistics gathered during the study illustrate the rise in radiology device recalls, as the recalls jumped from approximately 50 recalls in 2003 to more than 250 in 2011. Of the top ten most commonly recalled devices, the top two products (a linear accelerator and an image processing system) came from radiology with 176 and 153 recalls, respectively.
Recalls were increasingly caused by software design failures, the report found. This was often the case in the realms of radiology, cardiovascular, clinical chemistry, and the general hospital.
“Review and analysis of recall data helps to guide both FDA and industry in strategically focusing efforts that will improve the quality of medical devices, thereby improving patient health outcomes,” the report concluded.