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

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-medical-systems/9f8fd553-17ed-4b57-8731-2bcbf73c1c7a
Source feed: China

> China NMPA product recall for X-ray computed tomography (CT) system by Philips Medical Systems published December 22, 2014. Recall level: Level II. Philips (China) Investment Co., Ltd. and its manufacturer, Philips Medical Systems (Cleveland), Inc.

---

## 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: 2014-12-22
- Product Name: X-ray computed tomography (CT) system
- Recall Level: Level II
- Recall Reason: A potential problem has been identified in the vertical motor/brake of patient stents/scanning beds from a specific manufacturing batch that could cause uninstructed vertical movement of the patient stent/scanning bed. The vertical brake may fail while a patient is positioned on the scanning bed. While no injuries have been reported due to this failure mode, technicians, patients, or other users near the scanning bed could be injured by uninstructed vertical movement of the scanning bed if the vertical brake fails. No injury incidents have been reported to date.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips Medical Systems
- Summary: Philips (China) Investment Co., Ltd. and its manufacturer, Philips Medical Systems (Cleveland), Inc., initiated a voluntary Class II recall of specific X-ray Computed Tomography (CT) Systems. This action, published by the National Medical Products Administration (NMPA) and Shanghai Municipal Food and Drug Administration on December 22, 2014, followed an internal report on December 12, 2014. The recall addresses a potential defect in the vertical motor/brake of patient stents/scanning beds within certain production batches. This issue could lead to uninstructed vertical movement of the scanning bed, posing a potential risk of injury to patients, technicians, or other users near the equipment. Despite no reported injuries associated with this malfunction, the company proactively identified the hazard. The regulatory framework for this recall is established by the NMPA, overseeing medical device safety in China. As a required action, Philips is implementing corrective measures, deploying field service engineers to repair all 148 affected CT units sold in China. These repairs will utilize field change orders to rectify the vertical motor/brake issue, ensuring the safe and proper functioning of the scanning beds and mitigating potential user harm.

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