# China NMPA Product Recall - X-ray equipment; medical X-ray systems; angiography X-ray systems; angiography X-ray systems; medical angiography X-ray machines; medical angiography X-ray machines; medical angiography X-ray systems; medical angiography X-ray systems

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-china-investment-co-ltd/af40f153-7409-42ee-9e79-89619cd3f1fd/
Source feed: China

> China NMPA product recall for X-ray equipment; medical X-ray systems; angiography X-ray systems; angiography X-ray systems; medical angiography X-ray machines; medical angiography X-ray machines; medical angiography X-ray systems; medical angiography X-ray systems by Philips (China) Investment Co., Ltd. published January 14, 2020. Recall level: Level 2 Recall. Philips (China) Investment Co., Ltd. initiated a voluntary Level II recall of specific X-ray equipme

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips (China) Investment Co., Ltd. is voluntarily recalling X-ray equipment, medical X-ray systems, angiography X-ray systems, medical angiography X-ray machines, medical angiography X-ray systems, and medical angiography X-ray systems.
- Company Name: Philips (China) Investment Co., Ltd.
- Publication Date: 2020-01-14
- Product Name: X-ray equipment; medical X-ray systems; angiography X-ray systems; angiography X-ray systems; medical angiography X-ray machines; medical angiography X-ray machines; medical angiography X-ray systems; medical angiography X-ray systems
- Recall Level: Level 2 Recall
- Recall Reason: After multiple surges within a short period, a capacitor within the inverter of the Velara X-ray generator may fail. When this occurs, image acquisition is no longer possible. The failed capacitor will produce smoke and a burning odor in the room where the generator is located. If the system is dual-panel, X-ray acquisition may still be possible in other channels. If the system is single-panel, the equipment will be unusable until the capacitor is replaced.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips (China) Investment Co., Ltd.
- Summary: Philips (China) Investment Co., Ltd. initiated a voluntary Level II recall of specific X-ray equipment, including medical X-ray systems and angiography X-ray systems, announced on January 14, 2020. This action, overseen by the National Medical Products Administration (NMPA) and Shanghai Food and Drug Administration (SFDA), stems from an internal investigation (recall document 2018-IGTBST-015). The core issue identified is a potential failure of a capacitor within the inverter of the Velara X-ray generator. This failure can occur after the capacitor experiences multiple power surges in a short timeframe. When the capacitor fails, it leads to the inability to acquire images and may produce smoke and a burning odor from the generator. For single-panel systems, this renders the equipment unusable until the faulty component is replaced. Although no related injury incidents have been reported globally to date, Philips is taking this corrective action to address the product defect. Detailed information on affected product models, specifications, and batches is provided in a supplementary Medical Device Recall Event Report Form.

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