Philips Medical Systems (Cleveland) Inc: Medical Device Recall in 2015 - (Recall #: Z-1682-2015)
See the recall detail below. You can also see other recalls from the same firm in 2015.
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).
Class II
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.
Serial #'s: 11005, 11006, 11007, 11008, 11009, 11010, 11011, 11012, 11013, 11014 & 24061.
Worldwide Distribution -- US, including the states of NY, OH, & TX; and, the countries of Finland, Germany, Japan, Netherlands, South Korea, Spain, & Switzerland.
Voluntary: Firm initiated
