# China NMPA Product Recall - X-ray computed tomography (CT) equipment, Ingenuity CT, Brilliance 64

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-medical-systems/e83d4cab-32ad-4ae6-97cd-463ece6145c5/
Source feed: China

> China NMPA product recall for X-ray computed tomography (CT) equipment, Ingenuity CT, Brilliance 64 by Philips Medical Systems published December 07, 2016. Recall level: Level II. Philips (China) Investment Co., Ltd., representing Philips Medical Systems (Cleveland), Inc., initia

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. has initiated a voluntary recall of X-ray computed tomography (CT) equipment and X-ray computed tomography (CT) equipment.
- Company Name: Philips Medical Systems
- Publication Date: 2016-12-07
- Product Name: X-ray computed tomography (CT) equipment, Ingenuity CT, Brilliance 64
- Recall Level: Level II
- Recall Reason: When performing high-resolution head scans, the reconstructed images may exhibit image quality degradation, manifesting as: non-uniformity, CT value shift (greater than 5 Henle units), and reduced gray/white matter differentiation. This problem is most severe in high-resolution mode. The Philips factory reference pediatric scanning protocol defaults to high-resolution mode. The factory reference adult head scan protocol defaults to standard resolution mode, and this problem has not occurred. No injury incidents have been reported to date.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips Medical Systems
- Summary: Philips (China) Investment Co., Ltd., representing Philips Medical Systems (Cleveland), Inc., initiated a voluntary Class II recall for its X-ray Computed Tomography (CT) equipment, specifically Ingenuity CT and Brilliance 64 models. The recall, reported to the National Medical Products Administration (NMPA) on September 8, 2016, and publicly announced on December 7, 2016, addressed a critical image quality degradation issue. During high-resolution head scans, the reconstructed images could exhibit non-uniformity, CT value shifts exceeding 5 Henle units, and reduced differentiation between gray and white matter. This problem was most severe in high-resolution mode, which was the default setting for Philips' factory reference pediatric scanning protocols. No patient injuries have been reported globally due to this issue. As required actions, Philips is undertaking Field Corrective Actions (FCOs) through software upgrades. Philips field engineers will contact all affected customers to schedule and implement the necessary software updates to resolve the image quality deficiencies on the 118 affected units worldwide, including 117 units sold in China.

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