China NMPA Product Recall - Ophthalmic wide-field imaging system

Shanghai Zhongzhi Technology Application Development Co., Ltd. voluntarily initiated a Class II recall for its Ophthalmic Wide-Area Imaging System, model RetCam3, as reported on July 17, 2015, to the National Medical Products Administration (NMPA), formerly known as CFDA. The recall was prompted by the discovery that halogen bulbs in specific batches of the imaging system experienced a significantly shorter lifespan than expected, leading to premature burnout. These systems are used for routine ophthalmic imaging, including retinal, corneal, and external examinations. The affected products were identified by distinct equipment serial numbers, such as RC6047 and RC6057. To address this product quality issue, Shanghai Zhongzhi Technology Application Development Co., Ltd. proactively replaced the halogen bulbs in all identified units while they were still in the company warehouse. This corrective action ensures that the newly installed bulbs operate properly, maintaining the equipment's intended functionality and adherence to product performance standards under NMPA's regulatory oversight.