# China NMPA Product Recall - X-ray computed tomography (CT) equipment; X-ray computed tomography equipment; X-ray computed tomography equipment; positron emission tomography and X-ray computed tomography (PET) imaging system; X-ray computed tomography equipment; positron emission tomography and X-ray computed tomography (PET) imaging system

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-china-investment-co-ltd/d8b582a0-d7b5-45ed-9542-7f54a71d6885/
Source feed: China

> China NMPA product recall for X-ray computed tomography (CT) equipment; X-ray computed tomography equipment; X-ray computed tomography equipment; positron emission tomography and X-ray computed tomography (PET) imaging system; X-ray computed tomography equipment; positron emission tomography and X-ray computed tomography (PET) imaging system by Philips (China) Investment Co., Ltd. published July 08, 2019. Recall level: Level 3 Recall. Philips (China) Investment Co., Ltd. initiated a voluntary Class III recall on July 8, 2019, for sev

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. is voluntarily recalling X-ray computed tomography (CT) equipment, positron emission tomography (PET) systems, and related equipment.
- Company Name: Philips (China) Investment Co., Ltd.
- Publication Date: 2019-07-08
- Product Name: X-ray computed tomography (CT) equipment; X-ray computed tomography equipment; X-ray computed tomography equipment; positron emission tomography and X-ray computed tomography (PET) imaging system; X-ray computed tomography equipment; positron emission tomography and X-ray computed tomography (PET) imaging system
- Recall Level: Level 3 Recall
- Recall Reason: Some affected Brilliance CT, Brilliance iCT, Brilliance ICT SP, Ingenuity CT, Ingenuity TF, IQon Spectral CT, and Vereos PET/CT devices may experience issues such as phase marker deviation in step-by-step scan images.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips (China) Investment Co., Ltd.
- Summary: Philips (China) Investment Co., Ltd. initiated a voluntary Class III recall on July 8, 2019, for several models of its X-ray Computed Tomography (CT) and Positron Emission Tomography (PET)/CT equipment. This action, reported under the regulatory oversight of the National Medical Products Administration (NMPA) and Shanghai Food and Drug Administration, was prompted by the detection of a specific technical issue: phase marker deviation in step-scan images. The affected product lines include Brilliance CT, Brilliance iCT, Brilliance ICT SP, Ingenuity CT, Ingenuity TF, IQon Spectral CT, and Vereos PET/CT systems. These devices are used for medical imaging and diagnostics. A "Class III" recall signifies that the probability of adverse health consequences from the use of the product is remote. Philips (China) is undertaking this recall to address the identified anomaly and maintain product quality and patient safety. Customers with the specified equipment models are directed to consult the "Medical Device Recall Event Report Form" for detailed information regarding affected specifications and batches, and to understand the necessary corrective actions as part of the recall process. This proactive measure aligns with regulatory expectations for medical device manufacturers.

Company: https://www.globalkeysolutions.net/companies/philips-china-investment-co-ltd/65759337-23bf-4cad-9163-71c3b842aa8b/