China NMPA Product Recall - Anesthesia System

Datex-Ohmeda, Inc., through its reporting entity GE Healthcare Systems Trading Development (Shanghai) Co., Ltd., has initiated a voluntary recall of specific Anesthesia System models. This recall, published on December 19, 2025, under NMPA Index Number JGXX-2025-10185, addresses a critical safety concern involving Carestation 620, Carestation 650, and Carestation anesthesia systems equipped with certain power management boards. The primary issue identified is the unexpected shutdown and restart of these systems when their AC power supply is disconnected or interrupted. This malfunction poses a significant risk in a medical setting, where consistent and reliable operation of anesthesia equipment is paramount for patient safety. The recall is being conducted under the oversight of the National Medical Products Administration (NMPA), China's regulatory authority for medical devices. While the recall level was not explicitly specified, the action highlights the NMPA's commitment to ensuring the safety and efficacy of medical products available in the market. As a required action, Datex-Ohmeda, Inc. is voluntarily recalling the affected Anesthesia System models (National Medical Device Registration Certificate 20183080068). Detailed information regarding the specific models, specifications, and batch numbers subject to this recall is available in the "Medical Device Recall Event Report Form" attached to the official NMPA notification. This voluntary action aims to mitigate potential risks to patients by addressing the identified power management board issue.