Carl Zeiss (Shanghai) Management Co., Ltd. Voluntarily Recalls Radiosurgery System

Source: Website of the Shanghai Municipal Drug Administration

Carl Zeiss Shanghai Co., Ltd. Voluntarily Recalls Radiosurgical Systems

Carl Zeiss (Shanghai) Management Co., Ltd. Initiates Voluntary Recall of Radiosurgical Systems

Shanghai Drug Administration Medical Device Recall No. 2026-094

Carl Zeiss (Shanghai) Management Co., Ltd. reported that, during measurements of Ø 1.5 cm spherical applicators in inventory using a water phantom, one spherical applicator was found non-compliant with release requirements. Consequently, Carl Zeiss (Shanghai) Management Co., Ltd. has voluntarily recalled its Radiosurgical System (Registration Certificate No.: Guo Xie Zhu Jin 20163051978). The recall is classified as Class II. For detailed information regarding the models, specifications, and batches of the affected products, please refer to the “Medical Device Recall Event Report Form.”