# China NMPA Product Recall - X-ray computed tomography equipment, computed tomography scanning system

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-china-investment-co-ltd/881ee45d-38d4-4f22-a550-5bc535663684/
Source feed: China

> China NMPA product recall for X-ray computed tomography equipment, computed tomography scanning system by Philips (China) Investment Co., Ltd. published December 05, 2018. Recall level: Level 2 Recall. This document, published by the National Medical Products Administration (NMPA) on December 5, 2018,

---

## 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 computed tomography (CT) scanning systems.
- Company Name: Philips (China) Investment Co., Ltd.
- Publication Date: 2018-12-05
- Product Name: X-ray computed tomography equipment, computed tomography scanning system
- Recall Level: Level 2 Recall
- Recall Reason: The product may have a problem with the front cover of the frame falling off. This means that the strength of the glass fiber weakens at the connection point with the frame, causing the front cover to separate from the frame and fall, which may pose a risk to patients or users.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips (China) Investment Co., Ltd.
- Summary: This document, published by the National Medical Products Administration (NMPA) on December 5, 2018, details a voluntary Class II recall initiated by Philips (China) Investment Co., Ltd. The recall addresses a critical safety concern involving specific models of X-ray computed tomography (CT) equipment and CT scanning systems. The primary issue identified is the potential for the front cover of the gantry to detach. Investigations revealed that this problem stems from a specific supplier, where the glass fiber at the connection point with the gantry frame weakens, leading to the cover separating and falling. This malfunction presents a significant risk to both patients and users of the equipment. Philips (China) Investment Co., Ltd. is proactively recalling the affected devices, which include various CT equipment and CT scanning systems referenced by specific CFDA registration numbers. The recall is managed under the NMPA's regulatory framework, specifically referenced by NMPA Index No. JGXX-2018-11415 and Shanghai Food and Drug Administration Medical Device Recall 2018-277. Further details regarding affected product models are available in the attached "Medical Device Recall Event Report Form."

Company: https://www.globalkeysolutions.net/companies/philips-china-investment-co-ltd/65759337-23bf-4cad-9163-71c3b842aa8b/