China NMPA Product Recall - Image archiving and transmission system (Model: Centricity PACS-IW; Version: 3.7.3)

GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a Class III voluntary recall for its Centricity PACS-IW Image Archiving and Transmission System (version 3.7.3), as reported by the National Medical Products Administration (NMPA) on April 15, 2015. The recall addresses a critical software issue where the system may experience a database deadlock during image acquisition. This malfunction can lead to the integrity of acquired images being compromised, with the potential risk of one or more images going missing during medical examinations. While this poses a significant concern for diagnostic accuracy, GE Healthcare confirmed there have been no reports of actual patient injuries related to this defect. The affected product, identified by registration certificate CFDA (Imported) No. 20113700353, was sold or imported into China, with similar issues impacting regions including the USA, European Economic Area, and Canada. To mitigate the risk, GE Healthcare is implementing two key corrective actions: first, sending direct customer emails to inform users of the issue and provide guidance on safe operation; and second, developing and deploying a software upgrade to comprehensively resolve the underlying database deadlock problem and ensure image integrity.