China NMPA Product Recall - Plasma Surgical System (trade name: PULSAR)

Medtronic (Shanghai) Management Co., Ltd. initiated a voluntary Class III recall of its Plasma Surgical Systems, specifically the PULSAR II generators, as reported internally on August 17, 2016, and publicly announced by the National Medical Products Administration (NMPA) on September 30, 2016. This action followed internal testing which revealed that some units failed electromagnetic compatibility standards, specifically YY0505-2012 (IEC60601-1-2). The main issue identified was a fuse blowing during surge tests, preventing the device from powering on, completing self-tests, or activating correctly. While the company assessed a low likelihood of serious patient harm, Medtronic China proceeded with the recall as a responsible measure to minimize potential risks, operating under NMPA's medical device regulatory framework. Required actions include notifying distributors to retrieve all affected units (model PS100-102, covering 80 units sold in China) from the market. All recalled products will be subsequently disposed of by Medtronic.