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

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-medical-systems/2a414aeb-ea5a-4bea-bf9a-0204d022bcb5/
Source feed: China

> China NMPA product recall for X-ray computed tomography (CT) system by Philips Medical Systems published July 06, 2016. Recall level: Level III. The National Medical Products Administration (NMPA) published a Level III voluntary recall notice on

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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: 2016-07-06
- Product Name: X-ray computed tomography (CT) system
- Recall Level: Level III
- Recall Reason: The Brilliance and Ingenuity series of X-ray computed tomography (CT) devices have software issues that could lead to unexpected radiation and image incompleteness, resulting in rescanning or diagnostic problems.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips Medical Systems
- Summary: The National Medical Products Administration (NMPA) published a Level III voluntary recall notice on July 6, 2016, initiated by Philips (China) Investment Co., Ltd. The recall addresses a critical software issue found in Philips' Brilliance and Ingenuity series X-ray Computed Tomography (CT) systems, manufactured by Philips Medical Systems (Cleveland), Inc.

The primary concern is a software malfunction that can lead to unexpected radiation exposure and incomplete image data. This flaw may necessitate patient rescanning or introduce difficulties in diagnostic interpretation. Affected models encompass Brilliance ICT, Brilliance ICT SP, Ingenuity CTO, and Brilliance 64 CT. In China, 212 units were imported, with 199 having been sold to facilities.

In response, Philips, reporting internally on May 12, 2016, has informed all affected users and implemented a Field Corrective Action (PCO). This action involves deploying field engineers to contact customers and perform necessary software upgrades to resolve the identified safety and performance issues. Currently, no patient injuries have been reported in connection with this software defect.

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