China NMPA Product Recall - Medical Linear Accelerator

Elekta (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class III recall of several imported medical linear accelerator models, as publicly announced on September 28, 2021. This action falls under the regulatory purview of the National Medical Products Administration (NMPA). The core issue identified involves the D1 diode within the accelerator modulator. If this diode breaks, there is a potential for silicone oil and ceramic fragments to splash out during maintenance procedures, posing a safety risk to personnel in the maintenance area. Elekta has confirmed that this particular malfunction does not affect the clinical use or safety for patients. In response to this discovery, Elekta issued an important global field safety notice (internal number: 200-01-103-083). The required actions for this recall include the physical recall of affected medical linear accelerators, which covers various registration certificate numbers. Furthermore, maintenance personnel are instructed to adopt additional safety precautions when attending to diode faults to prevent potential injuries. Detailed information regarding the specific affected product models and batches is provided in the "Medical Device Recall Event Report Form."