# China NMPA Product Recall - X-ray computed tomography (CT) system

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-medical-systems/8f09e32f-c7e5-4956-8841-c23ae2824bb7/
Source feed: China

> China NMPA product recall for X-ray computed tomography (CT) system by Philips Medical Systems published December 15, 2015. Recall level: Class III Recall. Philips (China) Investment Co., Ltd., in coordination with its manufacturer Philips Medical Systems 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. is voluntarily recalling X-ray computed tomography (CT) systems.
- Company Name: Philips Medical Systems
- Publication Date: 2015-12-15
- Product Name: X-ray computed tomography (CT) system
- Recall Level: Class III Recall
- Recall Reason: Some scans unexpectedly set the Z-axis scan length to be longer than the user-defined value in the plan. However, this problem can only occur if the following three conditions are met simultaneously: the plan uses dual Surview (panoramic scan), the plan requests sagittal or coronal reconstruction, and the gantry is tilted. To date, there have been no reported injuries worldwide.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips Medical Systems
- Summary: Philips (China) Investment Co., Ltd., in coordination with its manufacturer Philips Medical Systems (Cleveland), Inc., initiated a voluntary Class III recall for specific X-ray Computed Tomography (CT) Systems. This action, reported to the National Medical Products Administration (NMPA) on November 17, 2015, and published December 15, 2015, addresses a critical software anomaly. The primary issue involves certain CT scans unexpectedly extending the Z-axis scan length beyond the user's defined plan. This error is contingent on three specific conditions: the use of dual Surview (panoramic scan), a request for sagittal or coronal reconstruction, and a tilted gantry. While the potential for this deviation exists, Philips has confirmed no patient injuries have been reported globally due to this issue. The recall impacts models such as Brilliance 64 and Ingenuity CT systems, affecting 78 units globally, with 57 units sold in China. Operating under the NMPA's regulatory guidance, Philips has implemented a Field Corrective Action (FCO reference FC072800642). The required actions involve Philips notifying all affected users and deploying field engineers to conduct essential software upgrades on the identified systems to ensure proper functionality and patient safety.

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