China NMPA Product Recall - Surgical navigation system, neurosurgical navigation system

Medtronic (Shanghai) Management Co., Ltd. initiated a voluntary Class III recall, announced on December 5, 2018, for its surgical navigation systems (Registration Certificate No.: 20163542291) and neurosurgical navigation systems (Registration Certificate No.: 20173546129). The recall was prompted by an identified issue within the neurosurgical application software (version 2.2.0 and above), where the biopsy depth gauge function displays inaccurate information. This inaccuracy occurs when users utilize the navigation projection function and set it to a planned length. The primary concern is that this defect could lead to the biopsy needle being inserted too deeply, potentially causing unintended biopsy of healthy brain tissue or damage to critical anatomical structures during surgical procedures. The action was reported under the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration (recall 2018-287), requiring Medtronic to recall affected products to mitigate potential patient risks associated with the software malfunction.