Philips Healthcare recalls Incisive CT, software version 5.0

Recall date

August 2, 2023

Source

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

Recall number

Z-2520-2023

FDA classification

Class II

Brand / firm

Philips Healthcare

Sold / distributed

US Nationwide Distribution

Why it was recalled

Philips has identified three software issues with compliance concerns to Subchapter J: Issue 1: Coronary Computed Tomography Angiography (CTA) scan may not be triggered at the optimal time. Issue 2: Use of aborted surview for scan planning will result in deviation from intended scan area. Issue 3: Actual clinical scan with bariatric (Noah) couch will deviate from the intended scan area if surview scan length is greater than 1832mm.

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, software version 5.0