China NMPA Product Recall - Digital X-ray imaging system

Siemens Healthcare GmbH has initiated a voluntary Class III recall of several digital X-ray radiography systems, as reported by Siemens Healthcare Systems Ltd. and published by the National Medical Products Administration (NMPA) on September 6, 2023. The recall stems from a critical issue identified as the possibility of improper assembly of the BABIX bracket fixing device during the installation of these systems. The affected products include various models of X-ray diagnostic systems, digital X-ray radiography fluoroscopy systems, and digital medical X-ray radiography systems, all registered under the NMPA's medical device regulations. These devices carry specific registration numbers such as Import No. 20133300467 and National Medical Device Registration Nos. 20153061347, 20183060421, 20152061269, and 20222060011. Under the oversight of the NMPA, Siemens Healthcare GmbH is undertaking this recall to address the assembly defect. While the document does not specify immediate actions beyond the recall itself, it indicates that detailed information concerning the specific models, specifications, and batches of affected products is available in an accompanying "Medical Device Recall Event Report Form." This action is part of the regulatory framework to ensure the safety and proper functioning of medical devices in the market.