# China NMPA Product Recall - X-ray computed tomography equipment

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-china-investment-co-ltd/e4fca565-e99b-4ede-bf9b-cb5a5218122a/
Source feed: China

> China NMPA product recall for X-ray computed tomography equipment by Philips (China) Investment Co., Ltd. published November 13, 2017. Recall level: Level 3 Recall. Philips (China) Investment Co., Ltd. announced a voluntary Class III recall for certain models of it

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. voluntarily recalls X-ray computed tomography equipment.
- Company Name: Philips (China) Investment Co., Ltd.
- Publication Date: 2017-11-13
- Product Name: X-ray computed tomography equipment
- Recall Level: Level 3 Recall
- Recall Reason: The software related to the product has some missing information elements in the Simplified Chinese user data package.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips (China) Investment Co., Ltd.
- Summary: Philips (China) Investment Co., Ltd. announced a voluntary Class III recall for certain models of its X-ray computed tomography equipment, reported to the National Medical Products Administration (NMPA) on November 13, 2017. The primary reason for this recall stems from the identification of incomplete information within the simplified Chinese user data package of the software integrated into the affected devices. This deficiency potentially impacts user understanding and proper operation of the equipment. These specific X-ray systems were imported under license numbers 20153300422 and 20133304134. While the document does not specify any inspection dates, Philips (China) proactively initiated this recall under the regulatory framework of the NMPA, demonstrating its commitment to product quality and patient safety. The required action involves the company's voluntary retrieval of these devices from the market to address the software discrepancies. Additional comprehensive details concerning the exact product models, specifications, and affected batches are thoroughly documented in the "Medical Device Recall Event Report Form" and its corresponding attachments, which provide essential information for stakeholders. This recall highlights the importance of accurate user documentation in medical device operation.

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