# China NMPA Product Recall - Positron Emission Tomography/X-ray Computed Tomography Imaging System (PET/CT)

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-medical-systen-cleveland-inc/9a4d9e8d-d4cf-4909-bfd2-76b76918a399/
Source feed: China

> China NMPA product recall for Positron Emission Tomography/X-ray Computed Tomography Imaging System (PET/CT) by Philips Medical Systen (Cleveland) Inc. published June 30, 2021. Recall level: Level 3 Recall. On June 30, 2021, the National Medical Products Administration (NMPA) announced a voluntary Class II

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips Medical Systems (Cleveland), Inc. is voluntarily recalling its PET/CT Imaging System.
- Company Name: Philips Medical Systen (Cleveland) Inc.
- Publication Date: 2021-06-30
- Product Name: Positron Emission Tomography/X-ray Computed Tomography Imaging System (PET/CT)
- Recall Level: Level 3 Recall
- Recall Reason: If severe wear on the shaft of the monitor bracket assembly is not identified, it may cause the monitor bracket assembly to fall off.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips Medical Systen (Cleveland) Inc.
- Summary: On June 30, 2021, the National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated by Philips Medical Systems (Cleveland), Inc. concerning specific models of its PET/CT Imaging Systems. The recall stems from a critical safety concern identified with the monitor bracket assembly. It was determined that severe wear on the monitor bracket assembly axis, if left unaddressed, could result in the detachment of the monitor bracket, posing a significant safety risk to both patients and operators during use. Philips (China) Investment Co., Ltd. reported this issue to the NMPA, leading to the voluntary recall action by the manufacturer, Philips Medical Systems (Cleveland), Inc. This measure is taken to ensure the continued safety and efficacy of their medical devices in accordance with established regulatory frameworks. The specific details regarding the affected product models, specifications, and batch numbers are provided in the "Medical Device Recall Event Report Form" attached to the NMPA's announcement. This proactive recall demonstrates the company's commitment to addressing potential product deficiencies to safeguard public health and maintain product quality standards.

Company: https://www.globalkeysolutions.net/companies/philips-medical-systen-cleveland-inc/ed7d764b-6bff-4901-aefb-c49a08c8414f/