Recall Z-1646-2012 · OUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

Philips Medical Systems (Cleveland) Inc

Ingenuity TF PET/MRI System v.3.7.1, 510(k) #K103483, Model #882380. The device is a diagnostic imaging system for fixed installations that combines Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI). The system does not expose the patient to any ionizing radiation. The MRI Subsystem produces cross-sectional images, spectroscopy images and/or spectra in any orientation of th

Date	May 22, 2012 (initiated Apr 13, 2012)
Status	Terminated
Reason	Software errors. A number of non-conformances were identified and corrected by Philips Medical for their Ingenuity TF PET/MRI Systems running software version 3.7.1. The firm states that these non-conformances stemmed from software and/or documentation errors, and that software corrections are being performed in order to 'improve the overall quality and functionality of the Ingenuity TF CT/MRI S
Root cause	Software design
Action	The firm, Philips Medical, sent an 'URGENT - Medical Device Correction' notification letter dated April 13, 2012 to all affected customers via Certified mail. The letter informs the customers of the firm's upcoming software update. It tells the customers that the software for the Ingenuity TF PET/MR system unit will be upgraded from version 3.7.1 to version 3.7.2 and that the update/upgrade will provide a number of improvements to the overall quality and functionality of the Ingenuity TF PET/MR System. The notification document states that Philips will be installing the system update to versio
Quantity	8units (2 units in U.S. & 6 units in other countries)
Distribution	Worldwide distribution: USA (nationwide) including states of: OH and NY; and countries of: China, Finland, Germany, South Korea, Spain, and Switzerland.
FDA record	Open on fda.gov

510(k) clearances named in this recall

K103483

INGENUITY TF PET/MR
Philips Healthcare (Cleveland), Nov 23, 2011