Philips Medical Systems (Cleveland) Inc recalls Ingenuity TF Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI), 882380, Philips Medical Systems.

Recalled June 3, 2015 · FDA recall Z-1682-2015 · Philips Medical Systems (Cleveland)

Hazard

It was noticed that the spectroscopy voxel map did not align with the anatomical images of the phantom. This resulted in incorrect orientation of the Chemical Shift Imaging (CSI) data. · FDA Class II

Units

10 units

Sold at

Worldwide Distribution -- US, including the states of NY, OH, & TX; and, the countries of Finland, Germany, Japan, Netherlands, South Korea, Spain, & Switzerland.

Description

It was noticed that the spectroscopy voxel map did not align with the anatomical images of the phantom. This resulted in incorrect orientation of the Chemical Shift Imaging (CSI) data.

Product

Ingenuity TF Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI), 882380, Philips Medical Systems. The device is a diagnostic imaging system for fixed installations that combines Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI).

Manufacturer(s)

Philips Medical Systems (Cleveland) Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →