Philips Medical Systems (Cleveland) Inc recalls Ingenuity Core Computed Tomography X-ray system, Model 728321

Recall date

October 13, 2016

Source

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

Recall number

Z-0597-2017

FDA classification

Class III

Brand / firm

Philips Medical Systems (Cleveland) Inc

Sold / distributed

Worldwide distribution. The products were shipped to the following states: AL, AZ, CO, GA, IN, KY, LA, MA, MN, NY, OH, PA, SC, TX, and UT. There are five (5) government accounts for this recall: DEPARTMENT OF VETERANS AF, VETERANS WAY AND LAMONT ST, Mountain Home, TN 37684; US ARMY EVANS COMMUNITY…

Why it was recalled

The product label does not include the correct current rating.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Ingenuity Core Computed Tomography X-ray system, Model 728321