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

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-medical-systems/ed5e46a7-2ccd-4007-8a89-22ab75e76055/
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. Philips (China) Investment Co., Ltd. initiated a voluntary Class III recall for specific X-ray Compu

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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: 2016-07-06
- Product Name: X-ray computed tomography (CT) system
- Recall Level: Level III
- Recall Reason: During production, two fasteners of different lengths were found to have been manufactured using stainless steel instead of the specified alloy steel. These stainless steel fasteners may have been used in the manufacture of the Ingenuity CT system. These fasteners were primarily used to secure components of the adjustment bracket within the system gantry. Analysis revealed that the stainless steel fasteners still meet 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 adjustment bracket requires periodic adjustments, it is anticipated that the stainless steel fasteners may require re-torsion at some point in the system's lifespan. Repeated torsion of these stainless steel fasteners could generate stresses approaching the fastener's ultimate yield strength. Therefore, although no fastener failure has been observed to date, Philips has decided to take the following field corrections to prevent the subsequent reuse of these stainless steel fasteners.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips Medical Systems
- Summary: Philips (China) Investment Co., Ltd. initiated a voluntary Class III recall for specific X-ray Computed Tomography (CT) systems, including the Ingenuity CT. This action was reported to the National Medical Products Administration (NMPA) on May 9, 2016, with public notification on July 6, 2016. The recall stems from a manufacturing deviation where two critical fasteners, intended to be made of alloy steel, were instead produced using stainless steel. These fasteners secure components of the adjustment bracket within the CT system gantry. Although no failures have been reported, Philips' analysis indicates that while the stainless steel fasteners initially meet tensile safety factors, repeated adjustments to the bracket could necessitate re-torsion of these components. Over time, repeated torsion might cause stresses approaching the ultimate yield strength of the stainless steel, potentially compromising the system's integrity. To proactively address this potential risk, Philips has implemented a Field Corrective Action. This involves direct communication with affected customers and the dispatch of Philips Field LLC engineers to replace the non-conforming stainless steel fasteners on all impacted equipment globally. This measure ensures the long-term reliability and safety of the CT systems in line with NMPA's medical device oversight.

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