China NMPA Product Recall - surgical lights

BERCHTOLD GmbH&Co.KG, a medical device manufacturer, in collaboration with its agent Stryker (Beijing) Medical Devices Co., Ltd., has initiated a voluntary Class II recall for specific surgical light models: Chromophare F528 and F628. This recall, reported to the National Medical Products Administration (NMPA) and publicized on April 18, 2019, addresses a manufacturing flaw in units produced between September 21, 2017, and November 13, 2018. The main issue stems from inadequate adhesive curing on the lamp covers, caused by reduced sandblasting during production. This defect presents a risk of internal components detaching, potentially leading to the lamp cover falling from the surgical light and causing temporary or reversible injury to medical staff or patients. Although 345 affected units were distributed in China, no related adverse events have been reported to date. Under the NMPA's regulatory guidelines, Stryker will inform customers and distributors, dispatch engineers for on-site inspections, and implement corrective actions. These actions include recall procedures and, if necessary, the replacement of faulty lampshades, which will then be destroyed. The affected surgical lights can continue to be used normally until these corrective measures are completed.