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

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-healthcare-suzhou-co-ltd/7f96f55f-83b4-4e2d-80e0-3caac3811475/
Source feed: China

> China NMPA product recall for X-ray computed tomography equipment by Philips Healthcare (Suzhou) Co., Ltd. published July 08, 2016. Recall level: Level 3 Recall. Philips Healthcare (Suzhou) Co., Ltd. is voluntarily recalling its X-ray Computed Tomography Equipme

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips Healthcare (Suzhou) Co., Ltd. voluntarily recalls X-ray computed tomography (CT) equipment.
- Company Name: Philips Healthcare (Suzhou) Co., Ltd.
- Publication Date: 2016-07-08
- Product Name: X-ray computed tomography equipment
- Recall Level: Level 3 Recall
- Recall Reason: The following two issues are software-related: Issue 1: Tracking Image Artifacts - Tracking scan images from CT angiography (CTA) examinations may display linear artifacts. Linear artifacts may cause scans to be automatically triggered at incorrect times, failing to capture contrast agent peaks in the imaged body parts, thus generating suboptimal CT images unusable for clinical diagnosis. Issue 2: 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 Healthcare (Suzhou) Co., Ltd.
- Manufacturing Company: Philips Healthcare (Suzhou) Co., Ltd.
- Summary: Philips Healthcare (Suzhou) Co., Ltd. is voluntarily recalling its X-ray Computed Tomography Equipment (CFDA Medical Device Approval Nos. 3300671, 20143300672) due to image artifacts, as reported to the National Medical Products Administration (NMPA) on May 19, 2016, with the recall published on July 8, 2016. This Class III recall affects models like Ingenuity Flex and Brilliance CT 16. The primary issues are software-related. First, tracking image artifacts may appear in CT angiography (CTA) scans, potentially causing incorrect scan triggering and generating suboptimal images unsuitable for diagnosis. Second, intermittent ring/dot image artifacts can occur in reconstructed images after a complete system power-off and power-on, particularly if a head scan is performed without air correction or a fast IQ check. No injuries have been reported in relation to these issues. Philips Healthcare (Suzhou) Co., Ltd. will issue a Field Correction Order (FCO) to affected customers across regions including Canada, Mexico, Germany, Singapore, and Japan. Field service engineers will contact customers to arrange the necessary software upgrades to resolve these identified deficiencies. Six units were sold and manufactured in China.

Company: https://www.globalkeysolutions.net/companies/philips-healthcare-suzhou-co-ltd/f697ee6b-76f7-4128-9e8c-71e7ebe08572/