China NMPA Product Recall - X-ray stereotactic radiosurgery system

Accuray Medical Equipment (Shanghai) Co., Ltd. initiated a voluntary Level II recall for its X-ray stereotactic radiosurgery systems, announced on March 17, 2021. The recall addresses a critical patient safety issue arising from the long-term use of the device's standard treatment bed. Over time, the connecting arm screws between the bed board and the motor may loosen. This defect can cause the bed board to tilt as a patient dismounts after treatment, creating a substantial risk of falls and potential health and safety hazards.

The affected products include X-ray stereotactic radiosurgery systems with specific registration numbers: CFDA (Imported) 2012 No. 3304401, CFDA Import Registration Nos. 20173321084, 20153051340, and 20153051341. This corrective measure is undertaken under the regulatory framework of the National Medical Products Administration (NMPA) in China. A Level II classification signifies that exposure to the product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. Accuray's required action is to voluntarily recall these systems to address and mitigate the identified safety risk, with further details on affected models and batches available in the Medical Device Recall Event Report Form.