Philips Medical Systems (Cleveland) Inc recalls Ingenuity TF PET/CT Model # 882456, computed tomography x-ray system

Recall date

June 24, 2019

Source

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

Recall number

Z-2193-2019

FDA classification

Class II

Brand / firm

Philips Medical Systems (Cleveland) Inc

Sold / distributed

Worldwide distribution. US nationwide including Puerto Rico, Canada, Mexico, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Cote D'Ivoir…

Why it was recalled

In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied

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 Model # 882456, computed tomography x-ray system