China NMPA Product Recall - Ventilator

VELA Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Level III recall of its Ventilator (Registration Certificate No.: 20163544759), as reported by the National Medical Products Administration (NMPA) on July 23, 2021. The recall was prompted by an significant labeling error where the company's ventilators were incorrectly marked with a statement implying "Authorized for Emergency use of this device for COVID-19 Pandemic." This was misleading because, while the U.S. Food and Drug Administration (FDA) utilizes Emergency Use Authorization (EUA) procedures for certain products during public health emergencies, VELA's devices were not authorized under an EUA. Instead, they had already secured clearance through standard FDA 510(k) provisions for their intended use. The company acknowledged that this mislabeling could confuse consumers regarding the product's regulatory status and application during the pandemic. As a corrective action, VELA Medical Devices (Shanghai) Co., Ltd. is undertaking this recall to rectify the miscommunication. Specific details regarding affected product models and batches are provided in the accompanying "Medical Device Recall Event Report Form."