# 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/895f9fb6-7059-4f69-b070-8ae08804bf2c/
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., along with its manufacturer Philips Medical Systems (Cleveland

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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: The system encountered an error when reaching the threshold during a non-gated contrast agent tracking clinical scan, displaying the error message "An error has occurred: Please try again. If the problem recurs, please contact customer service." This resulted in the scan sequence being canceled, causing contrast agent loss. If this problem occurs again, a rescan may be necessary. No adverse events have been reported to date.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips Medical Systems
- Summary: Philips (China) Investment Co., Ltd., along with its manufacturer Philips Medical Systems (Cleveland), Inc., initiated a voluntary Class III recall for specific X-ray Computed Tomography (CT) equipment. This recall, reported on November 28, 2016, and published by the National Medical Products Administration (NMPA) on December 29, 2016, addresses a critical performance issue. The affected products include Ingenuity CT and Brilliance 64 models utilizing software versions 4.1.6.XX030 or 4.1.6.XX032. A total of 68 units sold in China are impacted as part of a global recall effort. The primary problem arises during non-gated contrast agent tracking clinical scans, where the equipment malfunctions upon reaching a threshold. This malfunction results in the cancellation of the scan sequence and subsequent loss of contrast agent, requiring potential rescans. Although no adverse events have been reported, Philips has taken decisive action. The company is actively notifying all affected users and implementing Field Corrective Actions through on-site software updates to resolve the issue and ensure product reliability under the NMPA's regulatory oversight.

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