Philips Medical Systems (Cleveland) Inc recalls Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) sys…

Recall date

November 1, 2017

Source

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

Recall number

Z-0522-2018

FDA classification

Class II

Brand / firm

Philips Medical Systems (Cleveland) Inc

Sold / distributed

One domestic and 1 foreign consignee ( Spain)

Why it was recalled

One of the two wire channels mounted inside the Gantry Separation Unit (GSU) that is also used to secure the top two GSU covers, was missing mounting hardware.

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

What was recalled

Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system