China NMPA Product Recall - Medical diagnostic X-ray machine

Shenzhen Shentu Medical Imaging Equipment Co., Ltd. voluntarily initiated a Class III recall for its Medical Diagnostic X-ray Machines (Model SONTU100-DRF) following an internal audit reported on November 1, 2018. The recall, overseen by the National Medical Products Administration (NMPA), addresses non-compliance concerning incomplete instruction manuals. The main issue was a lack of comprehensive descriptions for trademarks, the product's application scope, and usage environment within the existing manual template. While these omissions did not impact product performance or normal customer use, the company undertook this corrective action to meet regulatory standards. The recall affects 26 units sold in China. Required actions involve notifying all affected customers through follow-up communications, informing them of the instruction manual discrepancies, and providing guidance on how to obtain the newly revised and updated manual. This recall specifically pertains to documentation issues and does not require the physical return or recall of the medical devices themselves, as they remain fully functional and safe for their intended purpose.