Philips Healthcare has issued a class 2 device recall for more than 400 of its CT scanners due to a software defect, according to the U.S. Food and Drug Administration (FDA).
In a notice dated April 1, the FDA said that a letter Philips sent to customers in February 2015 indicated that the defect was related to an inversion of the sign indication of the longitudinal position on some types of scans. Customers should refrain from using images derived from multiplanar reconstructions for identifying the absolute position of an intervention for feet-first patient orientation.
The recall affects some 424 scanners in the Brilliance CT 64-channel with Essence technology, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenuity Core128, and Ingenuity CT product lines. Philips field service engineers will be contacting customers to arrange installation of software designed to fix the problem.
