Z-1646-2012

Ingenuity TF PET/MRI System v.3.7.1, 510(k) #K103483, Model #882380. The device is a diagnostic imaging...

Name: Z-1646-2012 Ingenuity TF PET/MRI System v.3.7.1, 510(k) #K103483, Model #882380. The device is a diagnostic imaging...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2012-04-13
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2012-04-13 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of 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... on 2012-04-13. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1646-2012
Status: Terminated
Initiated: 2012-04-13
Posted: 2012-05-22
Terminated: 2013-08-05
Recalling firm: Philips North America LLC
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.
Product code: OUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Reason for recall: 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 tag: software
FDA 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 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.
Quantity in commerce: 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.
Product codes and lots: Serial Numbers 11004-11014 are subject to recall/software correction.

Product code OUO

K103483Class IIIngenuity Tf Pet/mrPhilips Healthcare (Cleveland) / cleared 2011-11-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)