China NMPA Product Recall - Clinical monitor

Edwards (Shanghai) Medical Supplies Co., Ltd. initiated a voluntary recall of its clinical monitors, as reported by the National Medical Products Administration (NMPA) on September 6, 2019. This report serves as an update to an earlier recall event form from March 15, 2019, signifying an expansion of the initial action. The primary concern prompting this recall is the potential for excessive liquid to seep into the equipment, which could lead to electrical short circuits or other significant operational issues, posing risks to users. The recall level for these clinical monitors (Registration Certificate No.: 20173212327) has been elevated to Level 1, indicating a high-risk situation where product use could cause serious adverse health consequences or death. This elevation underscores the severity of the identified defect and the urgency of the corrective measures. Under the oversight of the Shanghai Food and Drug Administration, Edwards (Shanghai) Medical Supplies Co., Ltd. is undertaking expanded corrective actions to address the issue. Detailed information regarding the specific models, specifications, and affected product batches is available in the "Medical Device Recall Event Report Form" attachment, guiding stakeholders on the scope of the recall. This proactive measure aims to mitigate potential hazards and ensure patient safety.