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

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.