# China NMPA Product Recall - Medical angiography X-ray system, medical angiography X-ray machine

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-china-investment-co-ltd/e332ee79-3376-4240-8a3d-1eda4020a69d
Source feed: China

> China NMPA product recall for Medical angiography X-ray system, medical angiography X-ray machine by Philips (China) Investment Co., Ltd. published March 06, 2019. Recall level: Level 2 Recall. Philips (China) Investment Co., Ltd. initiated a voluntary Class II recall of several medical angiog

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. is voluntarily recalling its medical angiography X-ray systems, including medical angiography X-ray machines.
- Company Name: Philips (China) Investment Co., Ltd.
- Publication Date: 2019-03-06
- Product Name: Medical angiography X-ray system, medical angiography X-ray machine
- Recall Level: Level 2 Recall
- Recall Reason: This may intermittently cause problems such as interrupted real-time perspective imaging or exposure.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips (China) Investment Co., Ltd.
- Summary: Philips (China) Investment Co., Ltd. initiated a voluntary Class II recall of several medical angiography X-ray systems and machines, as reported on March 6, 2019. This action was taken under the regulatory oversight of the National Medical Products Administration (NMPA) and specifically reported by the Shanghai Food and Drug Administration, reflecting China's framework for medical device safety. The recall was prompted by potential intermittent issues that could lead to interruptions in real-time fluoroscopic imaging or exposure during medical procedures. The affected products include various models identified by their registration certificate numbers (e.g., 国械注进20153301339, 国食药监械（进）字2014第3302214号). These devices are critical for diagnostic and interventional cardiology procedures, and any disruption in imaging could potentially impact patient safety and the effectiveness of medical interventions. A Class II recall signifies that the product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. Philips (China) is responsible for providing detailed information on the specific models, specifications, and affected batches through a "Medical Device Recall Event Report Form." The required action from the company is to execute this voluntary recall to mitigate potential risks associated with the identified imaging interruptions, ensuring the safety and reliability of its medical equipment in clinical settings.

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