China NMPA Product Recall - Magnetic resonance imaging system with Surgical Suite Option scanning bed

The National Medical Products Administration (NMPA) issued a recall notice on December 10, 2015, regarding Magnetic Resonance Imaging (MRI) systems manufactured by GE Medical Systems, LLC. The recall was initiated voluntarily by GE Medical Systems, LLC, and reported by its Chinese entity, GE Medical Systems Trading Development (Shanghai) Co., Ltd., on September 29, 2015. The primary concern involved specific MRI systems with a Surgical Suite Option Scanning Bed, which presented a risk of shifting during patient transfer between the MRI and operating table. This displacement could potentially cause delays in the treatment process, though no patient injuries were reported.

Under the NMPA's regulatory framework, provincial and municipal Food and Drug Administrations were instructed to enhance supervision and management of these products. A key detail of this recall is that the affected MRI systems were not sold in the Chinese market, limiting the direct corrective actions needed within China. The recall primarily impacted regions such as the USA and Japan. Appendix 1 detailed various models like Signa HDi, Signa HDxt, and Discovery MR750, all intended for clinical MRI image diagnosis.