China NMPA Product Recall - Mobile C-arm X-ray system

GE OEC Medical Systems, Inc., in cooperation with its affiliate GE Medical Systems Trade Development (Shanghai) Co., Ltd., has initiated a voluntary Level III recall for its Mobile C-arm X-ray System. This recall, published by the National Medical Products Administration (NMPA) on April 17, 2025, is a response to a critical non-conformance with the international safety standard IEC 60601-2-54. The primary issue identified is that the combined deviations of the length and width of the X-ray field relative to the system's field of view do not meet the specified requirements.

The affected devices hold National Medical Device Registration Certificates 20193060162 and 20243060420. While the document does not detail specific risks, a Level III recall generally indicates a situation where a product violates NMPA regulations but is not expected to cause serious adverse health consequences. The regulatory framework for this action falls under the NMPA's medical device oversight.

The required actions involve the implementation of this recall by GE OEC Medical Systems, Inc. Further comprehensive information regarding the specific models, specifications, and batches of the products involved is detailed in the "Medical Device Recall Event Report Form," which serves as an attachment to the NMPA's official announcement. The company is responsible for ensuring all necessary corrective actions are undertaken to address this non-conformance.