China NMPA Product Recall - Positron emission tomography and magnetic resonance imaging system

On March 27, 2015, Philips (China) Investment Co., Ltd., on behalf of manufacturer Philips Medical Systems (Cleveland), Inc., initiated a voluntary Class II recall for its Ingenuity TF Positron Emission Tomography and Magnetic Resonance Imaging (PET/MR) Systems. This action, reported to the National Medical Products Administration (NMPA) in China, addresses a significant software issue related to chemical shift imaging (CSI) data orientation. The core problem arises when the system exports DICOM enhanced MR spectral data objects for use with third-party software. The system incorrectly filled spectral data cells using a column-priority order, diverging from the DICOM standard which mandates a row-priority order. This technical error could lead to misalignment of CSI data with anatomical images, potentially compromising diagnostic accuracy. To rectify this, Philips has issued Field Correction Order (FCO88200489), notifying affected Ingenuity TF PET/MR users. Philips field service engineers are scheduled to contact customers globally to install the necessary software update, ensuring adherence to DICOM standards and restoring accurate image representation.