China NMPA Product Recall - Multifunctional Medical Image Processing and Management System Software

Carestream (Shanghai) Medical Devices Co., Ltd. initiated a Class II voluntary recall of its Multifunctional Medical Image Processing and Management System Software, specifically Image Suite versions 3.0 and 4.0. This recall, reported to the National Medical Products Administration (NMPA) on May 18, 2016, and published on August 29, 2016, addresses a critical software anomaly. The issue arises when the software receives Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scans that include specific patient orientation markers, such as 'Left' (L), 'Right' (R), 'Anterior' (A), and 'Posterior' (P). If these markers are configured to overlay the images, they may be displayed in a reversed orientation. This could potentially lead to misinterpretation of patient anatomy. The recall impacts 35 products distributed in Mainland China, Hong Kong, Singapore, and Malaysia.

In response, Carestream has outlined several required actions. The company is informing all affected users and distributors about the issue. Additionally, customers utilizing Image Suite for CT or MR image reception are advised to perform manual verification of all orientation markers until a software update is implemented. Carestream has developed a corrective software update for Image Suite, and its after-sales service representatives are coordinating on-site upgrades to resolve the identified display reversal problem.