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

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-medical-systems/f9c56bdd-f59b-4f41-8150-0c5077a05ad2/
Source feed: China

> China NMPA product recall for X-ray computed tomography equipment by Philips Medical Systems published August 30, 2016. Recall level: Level III. Philips (China) Investment Co., Ltd., in conjunction with its manufacturer Philips Medical Systems (

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. voluntarily recalls X-ray computed tomography equipment.
- Company Name: Philips Medical Systems
- Publication Date: 2016-08-30
- Product Name: X-ray computed tomography equipment
- Recall Level: Level III
- Recall Reason: During manufacturing, a fastener made of stainless steel instead of the specified alloy steel was discovered. This non-conforming fastener may have been used in the manufacture of the Brilliance CT Big Bore system. This fastener is primarily used to secure components of the adjustable bracket within the system's gantry. Analysis revealed that although the fastener is not made of the specified material, it still meets the application's tensile safety factor requirements. Nevertheless, given the material properties of stainless steel, these components may not be reusable (re-torsion). Since the adjustable bracket requires periodic adjustments, it is anticipated that this non-conforming fastener may need to be re-torsioned at some point in the system's lifespan. To date, no injuries have been reported globally. (Internal Recall Document No.: FCO 72800658)
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips Medical Systems
- Summary: Philips (China) Investment Co., Ltd., in conjunction with its manufacturer Philips Medical Systems (Cleveland), Inc., initiated a voluntary Level III recall for its X-ray Computed Tomography Equipment, specifically model 728243, which includes the Brilliance CT Big Bore system. The recall, publicly reported by the National Medical Products Administration (NMPA) on August 30, 2016, arose from a manufacturing deviation where a stainless steel fastener was inadvertently used instead of the specified alloy steel. This fastener is crucial for securing adjustable bracket components within the system's scanning gantry. Although internal analysis confirmed the stainless steel fastener met tensile safety factors, concerns were raised regarding its reusability after re-torsion, which may be required for periodic system adjustments throughout its operational life. A total of 24 units were identified as affected in China. Philips has proactively informed all impacted customers about this non-conformity and commenced Field Corrective Actions (FCOs) to implement necessary on-site corrections. Importantly, no patient injuries related to this manufacturing issue have been reported globally. This recall demonstrates Philips' adherence to product safety standards under the NMPA's medical device regulatory framework.

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