Medical device recalls nearly doubled over the past decade, according to a new report from the U.S. Food and Drug Administration called the Medical Device Recall Report.

Out of 1,190 recalls between fiscal years 2003 and 2012, the majority were for radiology devices.

Why? The report attributes the increase to the call for a reduction in unnecessary radiation exposure.
"Radiology device recalls increased in 2010 following enhanced media and FDA attention relating to concerns aimed at reduction of unnecessary radiation exposure," said the report.

Recalls for linear accelerators topped the list with a reported 176 recalls, due in large part to software issues, system compatibility (interoperability between treatment planning and treatment delivery systems), user interfaces (human factors), and dose calculation (clinical decision support software), according to the report. These errors accounted for more than two thirds of the recalls.

The second most commonly recalled products on the list were radiological image process systems, followed by infusion pumps, CT scanners, and automated external defibrillators.

The report attributes the increase in recalls largely to greater focus on, and attention to, improving product quality for these particular devices, with much of the reporting of recalls coming directly from the device companies.

More Industry Headlines