China NMPA Product Recall - Computed radiographic imaging system

Carestream (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class II recall of specific Computed Tomography (CT) imaging systems on December 2, 2014, under the regulatory oversight of the National Medical Products Administration (NMPA) and the Shanghai Municipal Food and Drug Administration. The recall targets Classic CR and Elite CR systems equipped with V5.7 software and the breast imaging component. The core issue is that when breast X-ray images are printed using the "multi-format printing" function, the system automatically scales them, rather than reproducing the actual size chosen by the user. This unintended scaling could potentially impair physicians' accurate interpretation of critical image details, such as microcalcifications, thereby affecting diagnostic precision. Carestream noted that this problem is confined to "multi-format printing" and does not impact electronic images or "single-image printing." To date, the company has not received any reports of harm to patients related to this issue. The recall specifically affects five Classic CR systems located in mainland China. Carestream is undertaking this action to ensure compliance with regulatory standards and mitigate any potential diagnostic discrepancies arising from the software anomaly.