Philips North America Llc recalls Spectral CT. Computed tomography X-ray system.

Recall date

May 29, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2034-2025

FDA classification

Class II

Brand / firm

Philips North America Llc

Sold / distributed

Domestic: AZ, CA, CO, FL, GA, HI, IN, KY, MA, MD, MN, NY, OH, OR, PA, TX, VT, WA, WV; Foreign: Australia, Austria, Belgium, China, Czech Republic, Denmark, Ecuador, France, Germany, Hong Kong, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Lithuania, Macao, Malaysia, Netherlands, New Zea…

Why it was recalled

Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional software issues that affect CT performance.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Spectral CT. Computed tomography X-ray system.