China NMPA Product Recall - Anesthesia machine

The National Medical Products Administration (NMPA) issued a notice regarding a voluntary global recall initiated by Dameca A/S (Denmark) for its Dameca MRI 508 and Siesta i Whispa anesthesia machines. The recall, reported by Philips (China) Investment Co., Ltd. on September 25, 2014, addresses a manufacturing oversight where certain production tests related to the auxiliary fresh gas outlet were not completed before the devices left the factory. This omission creates a potential risk of malfunction in these specific functions. While most device tests were successfully completed, the auxiliary fresh gas subsystem was not fully verified. The regulatory framework highlights that Dameca A/S, through its distributor Philips (China), voluntarily initiated this action. It's noted that no affected units were sold or imported into China. For devices globally, the required action depends on maintenance status: if annual preventative maintenance has been performed, no further action is necessary; otherwise, the missing tests must be executed. The NMPA also instructed local food and drug administration bureaus to enhance oversight of similar products.