China NMPA Product Recall - Image processing device

OLYMPUS MEDICAL SYSTEMS CORPORATION, in coordination with its China-based unit Olympus Trading (Shanghai) Co., Ltd., initiated a voluntary Level 3 recall of its CV-260 Image Processing Devices. The recall was announced on November 22, 2011, following a report dated November 1, 2011. The primary issue identified was the incorrect placement of electrical components in certain batches, which could lead to damage during power-on and result in image malfunctions. This defect was typically discovered by medical professionals during pre-operative equipment checks. While the malfunction did not pose an immediate risk of heat, fire, or smoke, and the probability of harm to human health was deemed extremely low, the National Medical Products Administration (NMPA) requested provincial, autonomous region, and municipal food and drug administrations to enhance supervision. The recall affects 229 units produced (92 imported into China) sold across Japan, China, South Korea, and other regions. As part of the corrective action, Olympus committed to tracing all affected products through sales records, notifying sales units, distributors, and hospitals, and deploying professional technicians to perform on-site repairs on all impacted devices.