China NMPA Product Recall - Specific electromagnetic wave therapy device

On January 18, 2019, the National Medical Products Administration (NMPA) announced a Level III voluntary recall initiated by Chongqing Aerospace Rocket Electronic Technology Co., Ltd. The recall pertains to certain electronically manufactured medical products, specifically model CO-10, from the 2018.05 batch (Registration No.: 渝食药监械（准）字2014第2260006号), impacting 10 units sold in Mainland China. The principal issue leading to this recall was the product's non-compliance with section 42.5 of the YY0306-2008 standard. This section mandates that certain parts, described as a "small piece," should require specialized tools for removal; however, it was discovered that this part could be removed without tools, indicating a potential safety or functional deviation. This action falls under the NMPA's regulatory oversight for medical device standards. In response, Chongqing Aerospace Rocket Electronic Technology Co., Ltd. has initiated corrective measures by notifying affected parties and commencing the recall of the identified batch, as documented in their Medical Device Recall Event Report Form. The product is generally indicated for adjunctive treatment of various conditions, including soft tissue injury and rheumatic joint disorders.