US FDA Issues Class 2 Device Recall of CT Scanners

The US Food and Drug Administration (FDA) issued a Class 2 Recall notice on April 1, 2015, for several Philips Healthcare (Best, The Netherlands) Computed Tomography (CT) scanners worldwide.

According to the FDA, “Philips discovered that a software defect exists in the marketed product wherein the sign indication of the longitudinal position of some types of scan is inverted.”

The CT systems affected are the Philips Healthcare Brilliance CT 64-channel scanner with Essence technology, the Brilliance iCT, the Brilliance iCT SP, the Ingenuity Core, the Ingenuity Core128, and the Ingenuity CT scanner.

Philips Healthcare already sent a customer information letter, dated February 5, 2015, to all affected customers. The letter identified the products affected, the problem found, and the action that the customer needed to take. The problem was determined to be in the software design, and Philips Healthcare informed their customers to refrain from using Multi Planar Reconstruction (MPR) derived images for identifying the absolute position of the intervention for feet-first patient orientation.

To correct the issue, Philips Healthcare has instructed field service engineers to contact affected customers and schedule on-site software upgrade installations.

Related Links:
Philips Healthcare
US Food and Drug Administration (FDA)