China NMPA Product Recall - pH detection system

Given Imaging, Inc. has initiated a voluntary Class II recall for its pH detection system, as reported by Covidien Medical Devices International Trading (Shanghai) Co., Ltd. This action, publicized by the National Medical Products Administration (NMPA) on March 17, 2021, addresses a significant product concern. Specifically, certain models and batches of the pH detection system (Registration Certificate No.: 20153073986) may fail to properly adhere to capsules. This malfunction is attributed to the equipment tilting or bending during operation, which could compromise the device's intended diagnostic function. The NMPA, serving as the regulatory authority, classified this as a Class II recall, indicating a situation where the use of, or exposure to, a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The company's required action is to retrieve the affected pH detection systems from the market. Comprehensive details on the specific models, specifications, and batch numbers impacted by this recall are documented in the "Medical Device Recall Event Report Form" attachment. This proactive measure aims to ensure product reliability and patient safety by addressing the identified operational flaw.