Philips North America Llc recalls Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.

Recall date

November 16, 2024

Source

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

Recall number

Z-0583-2025

FDA classification

Class II

Brand / firm

Philips North America Llc

Sold / distributed

Worldwide - US Nationwide distribution in the states of AR, AZ, CA, FL, GA, HI, IN, KY, MA, MD, MN, NY, OH, OR, PA, TX, VT, WA, WV and the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, Ecuador, France, Germany, Hong Kong, Israel, Italy, Japan, Jordan, Macao, Malaysia, Ne…

Why it was recalled

Potential for a plan box not updated issue during Interventional procedure with Spectral CT that may lead to a collision with the operator or with the needle placed inside the patient, and an incorrect patient ID software issue that may lead to misdiagnosis.

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 and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.