Philips Medical Systems (Cleveland) Inc recalls Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems

Recall date

July 23, 2015

Source

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

Recall number

Z-2491-2015

FDA classification

Class II

Brand / firm

Philips Medical Systems (Cleveland) Inc

Sold / distributed

Product was shipped to the following states: NY, OH & TX. Product was also shipped to the following countries: Finland, Germany, Hong Kong, Japan, Netherlands, South Korea, Spain & Switzerland.

Why it was recalled

Philips Healthcare has become aware of a problem in which the Ingenuity TF PET/MR PET Reconstruction Server (PRS) database may lock up after an MR acquisition is completed and before a PET acquisition is begun, even though no actual database lockup issue has been reported in the field-installed Ingenuity TF PET/MR systems.

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/MR, Diagnostic Imaging System , Philips Medical Systems