# China NMPA Product Recall - Medical diagnostic X-ray system

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-medical-systems/fbaa27d8-dd08-41a5-b1ed-b17b3b7d86be/
Source feed: China

> China NMPA product recall for Medical diagnostic X-ray system by Philips Medical Systems published November 26, 2018. Recall level: Level 3 Recall. Philips Medical Systems DMC GmbH, through its agent Philips (China) Investment Co., Ltd., initiated 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips Medical Systems DMC GmbH voluntarily recalls medical diagnostic X-ray systems.
- Company Name: Philips Medical Systems
- Publication Date: 2018-11-26
- Product Name: Medical diagnostic X-ray system
- Recall Level: Level 3 Recall
- Recall Reason: Philips has detected an issue in CombiDiagnost that could pose a potential risk to patients or users if it recurs: 1. kV/mA locking fails to function as intended: The locking function is designed for fluoroscopy only. When enabled, it preserves current radiation parameters (kV and mA values) to maintain image consistency. This is relevant to structures being examined (e.g., knees or shoulders), where the detector dose is significantly affected by direct radiation. Due to a software defect, after activating the locking function, the mA value increases instead of being locked when the operator restarts fluoroscopy several times, resulting in an increased radiation dose to the patient. 2. Aborts stitching after the first image when using the SkyPlate detector: If there is improper synchronization between the SkyPlate detector and the system, artifacts will be present in the preview offset image. If this occurs, the system software will determine that the preview image buffer is unavailable when acquiring the first part of the stitching run, and will therefore terminate the run. The stitching run will need to be repeated. (Internal recall number: FCO 70900042)
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips Medical Systems
- Summary: Philips Medical Systems DMC GmbH, through its agent Philips (China) Investment Co., Ltd., initiated a voluntary Class III recall of its medical diagnostic X-ray systems, as reported to the National Medical Products Administration (NMPA) on November 14, 2018. The recall stems from a software defect that presents two primary issues. Firstly, the kV/mA lockout function, intended to maintain consistent radiation parameters during fluoroscopy, malfunctions. Due to the defect, the mA value can increase unexpectedly after the lockout function is activated and fluoroscopy pulses are restarted, leading to an increased radiation dose for the patient. Secondly, when using the SkyPlate detector, the system may abort the stitching process after the first image due to improper synchronization, resulting in artifacts in the preview image and requiring repeated runs. While these issues were identified, the affected batches of the CombiDiagnost R90 model were not sold in China. This proactive measure aims to address potential patient and user risks associated with these identified software anomalies.

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