—#109141

Product

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 the internal structures of the whole body. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient 's body (specific pharmaceuticals are used for whole body, brain, and other organ imaging). The PET and MRI portion of the system can be used either as an integrated system or as a stand-alone MRI or PET system. The MRI subsystem provides data suitable for use in attenuation correction of the PET acquired data.

FDA product code: OUO — Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K103483
Affected lot / code info: Serial Numbers 11004-11014 are subject to recall/software correction.

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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 version 3.7.2 software through a Field Change Order. This will be implemented free-of-charge and will include complementary PET/MR application training. For further information, call toll-free telephone number which they can call 1-800-722-9377 and follow the menu options to reach a Customer Solutions Engineer.

Recalling firm

Firm: Philips Medical Systems (Cleveland) Inc
Address: 595 Miner Road, Cleveland, Ohio 44143-2131

Distribution

Distribution pattern: Worldwide distribution: USA (nationwide) including states of: OH and NY; and countries of: China, Finland, Germany, South Korea, Spain, and Switzerland.

Timeline

Recall initiated: 2012-04-13
Posted by FDA: 2012-05-22
Terminated: 2013-08-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #109141. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.