Ingenuity Tf Pet/MR

• • Terminated Z-2491-2015 FDA Class II ·initiated 23 Jul 2015

  Philips Healthcare has become aware of a problem in which the Ingenuity TF PET/MR PET Reconstruction Server (PRS) database may lock up after an MR acquisition is completed and before a PET acquisition is begun, even though no actual database lockup issue has been reported in the field-installed Ingenuity TF PET/MR systems.

• • Terminated Z-1682-2015 FDA Class II ·initiated 11 Mar 2015 ·on shared 510(k) K103483

  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.

• • Terminated Z-1780-2015 FDA Class II ·initiated 6 Mar 2015

  The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

• • Terminated Z-1646-2012 FDA Not yet classified ·initiated 13 Apr 2012

  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

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K103483 ↗

FDA Product Code

OUO

Device Class

Class II

Regulation

21 CFR Part 892.1200

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Philips Iqon Spectral CT

  Class II

  FDA 510(k) K133674 Active Cleared 21 Nov 2014

• Iterative Reconstruction Technique Software Application

  Class II

  FDA 510(k) K113483 Active Cleared 26 Sep 2012

• Imr Software Application

  Class II

  FDA 510(k) K123576 Active Cleared 7 Jun 2013

• Ingenuity Digital PET/CT Open recall

  Class II

  FDA 510(k) K123599 Active Cleared 12 Jul 2013

• Brilliance Ict

  Class II

  FDA 510(k) K131773 Active Cleared 24 Sep 2013