China NMPA Product Recall - Medical dry film

On May 6, 2022, Agfa NV Medical Dry Film initiated a voluntary Class III recall for specific models and batches of its medical dry film products. The recall was reported by Agfa Medical Systems Equipment (Shanghai) Co., Ltd. and is overseen by the National Medical Products Administration (NMPA) of China. The primary reason for this action stems from the discovery of incorrect information encoded on the RFID tags associated with the affected products. This data integrity issue necessitated a corrective measure to ensure proper product identification and functionality. While a Class III recall typically indicates a low probability of adverse health consequences, Agfa NV's proactive response demonstrates its commitment to product quality and adherence to regulatory standards. The NMPA framework requires companies to report such deficiencies and implement necessary recalls to uphold patient safety and product efficacy. Detailed information regarding the specific models and batches subject to this recall was provided in a "Medical Device Recall Table" and an "Medical Device Recall Event Report Form."