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

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-medical-systems/a4147fed-e299-445e-bafe-92f253e51bc4/
Source feed: China

> China NMPA product recall for X-ray computed tomography equipment, X-ray computed tomography equipment by Philips Medical Systems published December 29, 2016. Recall level: Level III. Philips (China) Investment Co., Ltd. initiated a voluntary Level III recall for various X-ray Comput

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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: 2016-12-29
- Product Name: X-ray computed tomography equipment, X-ray computed tomography equipment
- Recall Level: Level III
- Recall Reason: During a CT scan, after a command is issued, the patient support bed may fail to move horizontally, possibly due to a mechanical connection malfunction. The system cannot automatically detect this malfunction and therefore cannot stop the scan or warn the user.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips Medical Systems
- Summary: Philips (China) Investment Co., Ltd. initiated a voluntary Level III recall for various X-ray Computed Tomography (CT) Equipment, including Ingenuity and Brilliance series, manufactured by Philips Medical Systems (Cleveland), Inc. This recall was reported on November 7, 2016, and publicly announced by the National Medical Products Administration (NMPA) on December 29, 2016. The core issue involves a potential mechanical connection failure that prevents the patient support bed from moving horizontally during a CT scan. A significant concern is the equipment's inability to automatically detect this malfunction, halt the scan, or alert the user, which could pose a safety risk. Although only two such failures were reported over ten years among 5000 potentially affected systems, the company is taking action under NMPA guidelines, referencing specific national medical device registration certificates. The required corrective action involves Philips' field engineers contacting affected customers globally, including 1152 units imported and sold in China, to issue Field Correction Orders (FCOs) to resolve the identified technical deficiency.

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