# China NMPA Product Recall - Mobile X-ray machine

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-medical-systems/154de701-b3ba-47b3-851d-45b420bca18e/
Source feed: China

> China NMPA product recall for Mobile X-ray machine by Philips Medical Systems published September 09, 2014. Recall level: . Philips Medical Systems DMC GmbH, in collaboration with its Chinese entity, Philips (China) Investme

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips Medical Systems DMC GmbH of Germany has recalled its mobile X-ray machines.
- Company Name: Philips Medical Systems
- Publication Date: 2014-09-09
- Product Name: Mobile X-ray machine
- Recall Reason: If the system is first run on an insulated floor or carpet and then on an uninsulated, electrically contacted surface, electrostatic discharge can cause the system's digital motion control (DMC) board to malfunction, resulting in unexpected movements such as increased speed or changes in direction.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips Medical Systems
- Summary: Philips Medical Systems DMC GmbH, in collaboration with its Chinese entity, Philips (China) Investment Co., Ltd., initiated a voluntary global recall of its mobile X-ray machines (CFDA (Imported) Registration Certificate Nos. 2014 No. 2300530 and 2014 No. 2300531). This recall was reported to China's National Medical Products Administration (NMPA) on September 1, 2014, based on an internal report dated August 26, 2014.

The primary issue identified was a malfunction in the system's Digital Motion Control (DMC) board. This defect could arise from electrostatic discharge when the machine is transitioned from an insulated surface, such as a carpet, to an uninsulated, electrically contacted surface. Such an event might lead to unexpected system movements, including changes in speed or direction. While the recall was global, Philips confirmed that the affected batches of these mobile X-ray machines were not sold in China.

Under the NMPA's regulatory framework, Philips undertook this proactive measure. Given that the specific affected products were not distributed in the Chinese market, direct corrective actions for consumers in China were not required. However, the NMPA requested provincial and municipal food and drug administrations to enhance their supervision and management of similar medical devices, ensuring continued product safety and compliance.

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