China NMPA Product Recall - Ophthalmic wide-field imaging system

This National Medical Products Administration (NMPA) document details a voluntary Level II recall initiated by Shanghai Zhongzhi Technology Application Development Co., Ltd., the responsible unit in China for products manufactured by Clarity Medical Systems. Published on July 17, 2015, the recall concerns the Ophthalmic Wide-Area Imaging System, specifically the RetCam3 Model. The core issue identified was an incorrect calculation of gestational age information within the device's user interface after a patient's age was entered. This software defect affects devices running software versions 6.0.x, 6.1, and 6.2.x, impacting a significant number of units with various serial numbers across China. In response to this critical defect, Shanghai Zhongzhi Technology Application Development Co., Ltd. has mandated a corrective action. All affected Ophthalmic Wide-Area Imaging Systems, identified by their serial numbers and software versions, are required to undergo a software version upgrade. This action aims to rectify the inaccurate age calculation, ensuring the device provides correct information for ophthalmic imaging, including retinal, corneal, and external imaging. The recall operates under the regulatory oversight of the NMPA (formerly CFDA), emphasizing patient safety and device accuracy in medical applications.