China NMPA Product Recall - DuraDiagnost Digital Medical X-ray Imaging System

Philips Healthcare (Suzhou) Co., Ltd. initiated a voluntary Level II recall for its DuraDiagnost Digital Medical X-ray Imaging System in January 2015, as reported to the National Medical Products Administration (NMPA) of China. The recall stems from a critical manufacturing issue: improper installation of T-nuts in the system’s assembly. This defect can lead to serious safety hazards, including the potential detachment of the X-ray tube assembly from its column, the detector box from the chest X-ray frame, or instability and wobbling of the bed panel. Such malfunctions pose a direct risk of injury to both patients and medical personnel. Under the regulatory oversight of the NMPA, with registration details handled by the Jiangsu Food and Drug Administration, Philips Healthcare (Suzhou) Co., Ltd. is undertaking specific corrective actions. These actions include notifying all affected DuraDiagnost product users through on-site safety notices. Furthermore, Philips after-sales service engineers are mandated to conduct comprehensive inspections of all installed equipment. During these inspections, they will install enhanced, new fixing structures for both the X-ray tube column and the chest X-ray frame to prevent future reinstallation errors. Additionally, engineers will carefully verify and adjust the orientation of the eight T-nuts on the bed panel floating frame to ensure proper and secure fastening, thereby mitigating the risk of panel movement. The recall affects 72 units manufactured or imported, with 29 units distributed within China.