PHILIPS HEADQUARTERS CAMBRIDGE recalls Incisive CT Power- Whole-body computed tomography (CT) X-Ray System Model Number: 728148 (OUS)

Recall date

April 12, 2023

Source

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

Recall number

Z-1624-2023

FDA classification

Class II

Brand / firm

PHILIPS HEADQUARTERS CAMBRIDGE

Sold / distributed

AR, CA, OK, TX Foreign: Country Argentina Australia Austria China Colombia Czech Republic Dominican Rep France Germany Guadeloupe Hong Kong India Japan Kuwait Latvia Lithuania Netherlands Norway Portugal Romania Spain Switzerland Taiwan Thailand United Kingdom Vietnam

Why it was recalled

Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is required

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

What was recalled

Incisive CT Power- Whole-body computed tomography (CT) X-Ray System Model Number: 728148 (OUS)