# China NMPA Product Recall - Digital medical X-ray imaging system

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-medical-systems/f2eda7d3-a1d0-4303-91c5-30baefb0de3a/
Source feed: China

> China NMPA product recall for Digital medical X-ray imaging system by Philips Medical Systems published September 04, 2014. Recall level: . Philips Medical Systems DMC GmbH initiated a voluntary global recall of its Digital Medical X-ray Im

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips Medical Systems DMC GmbH of Germany has issued a recall for its digital medical X-ray imaging systems.
- Company Name: Philips Medical Systems
- Publication Date: 2014-09-04
- Product Name: Digital medical X-ray imaging system
- Recall Reason: The foot pedal of the patient support used for image stitching can be fixed in the upper position. If the fixing clip (hook) is not properly adjusted to its correct position, the foot pedal cannot be securely held. If it falls, it may injure the operator's or patient's feet (e.g., when the support is moved or when the operator fails to properly secure the foot pedal while moving it upwards). This situation can occur for the following reasons: improper hook adjustment; operator not noticing the hook is not in its correct position; patient support being moved (rotated); hook not secured; foot in a "danger zone".
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips Medical Systems
- Summary: Philips Medical Systems DMC GmbH initiated a voluntary global recall of its Digital Medical X-ray Imaging System (DigitalDiagnost) in August 2014, as reported by its distributor, Philips (China) Investment Co., Ltd. The National Medical Products Administration (NMPA) published this information on September 4, 2014. The core issue identified was that the foot pedal of the patient stand, integral for image stitching, could become insecure if its retaining clip, or hook, was not correctly adjusted. This deficiency meant the foot pedal might not be securely fixed, creating a potential safety hazard where it could fall and cause injury to an operator or patient’s foot during equipment movement or improper securing. The regulatory framework governing this product in China included a CFDA (Imported) registration certificate. Despite the global recall, Philips (China) Investment Co., Ltd. confirmed that zero units of the affected batches were imported or sold within China. Consequently, specific corrective actions for deployed units were not applicable in the Chinese market. Nevertheless, provincial, autonomous region, and municipal food and drug administrations were instructed to enhance their oversight and management of such products to ensure public safety.

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