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

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-medical-systems/93722013-4428-4b72-b600-def1e6dab793/
Source feed: China

> China NMPA product recall for Positron emission tomography and magnetic resonance imaging system by Philips Medical Systems published March 27, 2015. Recall level: Level 2 Recall. On March 27, 2015, Philips (China) Investment Co., Ltd., on behalf of manufacturer Philips Medical S

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. is voluntarily recalling its positron emission tomography (PET) and magnetic resonance imaging (MRI) systems.
- Company Name: Philips Medical Systems
- Publication Date: 2015-03-27
- Product Name: Positron emission tomography and magnetic resonance imaging system
- Recall Level: Level 2 Recall
- Recall Reason: When using third-party software, the spectral voxel map may become misaligned with the anatomical image, resulting in incorrect orientation of the chemical shift imaging (CSI) data. This phenomenon only occurs when the Scan Console exports DICOM-enhanced MR spectral data objects; the filling of the spectral data cell (5600, 0020) is incorrect. The DICOM standard specifies that the data cell should be filled using voxels of the spectral curve data in row-priority order; in other words, starting from row 1, column 1 to row 1, then column 1 of each consecutive row. However, the current system uses column-priority order to fill the data cell.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips Medical Systems
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/philips-medical-systems/91e33b43-88a2-4a53-9bcd-1d32f1abde47/