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

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-medical-systems/5a0a5490-7ee6-4229-baf0-910f52948ea0/
Source feed: China

> China NMPA product recall for X-ray computed tomography (CT) system by Philips Medical Systems published November 27, 2015. Recall level: Level III. Philips (China) Investment Co., Ltd., on behalf of manufacturer Philips Medical Systems (Cleveland),

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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: 2015-11-27
- Product Name: X-ray computed tomography (CT) system
- Recall Level: Level III
- Recall Reason: The following three issues are related to the software: Issue 1: Image localization accuracy report states that the image rotation calibration procedure performed by the field service engineer passed, but the ultrafast scan mode failed to generate the correct angular offset values. Incorrect angular offsets can affect the accuracy of radiotherapy planning. Issue 2: Tracking image artifacts - Tracking scan images from CT angiography (CTA) examinations may show linear artifacts. Linear artifacts may cause automatic scanning to be triggered at the wrong time, failing to capture contrast agent peaks in the imaged body parts, thus generating suboptimal CT images that cannot be used for clinical diagnosis. Issue 3: Ring/dot image artifacts caused by X-ray measurements - After a complete system power-off and power-on, if a head scan is performed without air correction and without using a fast IQ scan after startup, intermittent ring/dot image artifacts may appear in the reconstructed images.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips Medical Systems
- Summary: Philips (China) Investment Co., Ltd., on behalf of manufacturer Philips Medical Systems (Cleveland), Inc., initiated a voluntary Class III recall of its X-ray Computed Tomography (CT) Systems. This action was reported to the National Medical Products Administration (NMPA) on November 27, 2015, addressing three significant software-related deficiencies that could impact diagnostic accuracy and treatment planning. The identified issues include inaccurate image positioning, where incorrect angular offsets might affect radiotherapy planning. Additionally, tracking scan images in CT angiography (CTA) examinations displayed linear artifacts, potentially resulting in suboptimal image quality unsuitable for clinical diagnosis. Lastly, specific head scans performed after a system power cycle were prone to intermittent ring/dot artifacts if air correction or a rapid IQ scan was not utilized. This global recall encompasses 254 units imported into China. No injury incidents have been reported. Philips has proactively issued Field Corrective Actions (FCO 72800635), notifying affected users, and its field engineers are coordinating software upgrades with customers to resolve these issues and ensure the safe and intended performance of the CT systems.

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