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

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-advanced-energy-llc/dfcffbfa-ab0c-49a2-a057-90ba9a663776/
Source feed: China

> China NMPA product recall for Plasma Surgical System (trade name: PULSAR) by Medtronic Advanced Energy, LLC published September 30, 2016. Recall level: Level III. Medtronic (Shanghai) Management Co., Ltd. initiated a voluntary Class III recall of its Plasma Surgi

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic (Shanghai) Management Co., Ltd. voluntarily recalls plasma surgical systems.
- Company Name: Medtronic Advanced Energy, LLC
- Publication Date: 2016-09-30
- Product Name: Plasma Surgical System (trade name: PULSAR)
- Recall Level: Level III
- Recall Reason: Medtronic discovered during a test that some PULSAR II generators failed the YY0505-2012 (IEC60601-1-2) electromagnetic compatibility test. The fuse blew during the surge test, preventing the device from powering on, completing self-tests, and activating properly. While there have been no reports of PULSAR II generators failing IEC tests in other countries, and the likelihood of such malfunctions causing serious injury or death to patients is very low, Medtronic China, acting responsibly, has decided to initiate this recall to minimize potential risks.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Advanced Energy, LLC
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/medtronic-advanced-energy-llc/fbed24df-b7e6-411b-a0cb-d337193937b3/