China NMPA Product Recall - Digital X-ray machine

Philips Medical (Suzhou) Co., Ltd., operating under the regulatory framework of China's National Medical Products Administration (NMPA), initiated a voluntary, level two global recall for 90 units of its Digital X-ray Machines. This recall was officially reported on August 2, 2022, addressing a significant technical malfunction. The core issue arises when, after restarting the equipment and switching from the default 'Height 2' setting to the 'Wallstand VS2' chest X-ray stand, the displayed image orientation is incorrect. This defect is attributed to the Wallstand VS2 control system, which erroneously rotates the selected ionization chamber detection field by 90 degrees. The recall impacts various DigitalDiagnost models, including the C50, 65 HAT, and 2000 series, with specific serial numbers identified. Philips Healthcare (Suzhou) Co., Ltd. has not received any adverse event reports related to this particular issue. As a required action, Philips will notify all affected users (FC071200225) and provide essential firmware updates for the impacted devices. Company engineers are tasked with contacting users directly to arrange and conduct the necessary on-site corrective actions, ensuring the safe and proper functionality of the equipment.