# China NMPA Product Recall - Digital medical X-ray imaging system

Source: https://www.globalkeysolutions.net/records/china_product_recall/carestream-health-inc/42385829-61c3-4e83-8ee8-8d84bcdaafbf/
Source feed: China

> China NMPA product recall for Digital medical X-ray imaging system by Carestream Health Inc. published August 13, 2015. Recall level: Class II Recall. Carestream Asia Pacific Investment Management (Shanghai) Co., Ltd., on August 13, 2015, initiated a 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Carestream Asia Pacific Investment Management (Shanghai) Co., Ltd. voluntarily recalls digital medical X-ray imaging systems.
- Company Name: Carestream Health Inc.
- Publication Date: 2015-08-13
- Product Name: Digital medical X-ray imaging system
- Recall Level: Class II Recall
- Recall Reason: When using the DRX-Evolution system with software version V5.6 or V5.7, if technicians rely entirely on the automatic stitching software instead of external reference markers or measurement tools to construct the composite image when generating ultra-long images using the "automatic stitching" option, stitching errors that the software cannot recognize may occur in image alignment. However, this problem can be identified and corrected when using the "manual stitching" option.
- Discovering Company: Carestream Asia Pacific Investment Management (Shanghai) Co., Ltd.
- Manufacturing Company: Carestream Health Inc.
- Summary: Carestream Asia Pacific Investment Management (Shanghai) Co., Ltd., on August 13, 2015, initiated a Class II voluntary recall of its Digital Medical X-ray Imaging Systems, specifically DRX-Evolution systems utilizing software versions V5.6 or V5.7. This action was reported to the National Medical Products Administration (NMPA). The recall stemmed from a discovered issue where the "Auto Stitching" function, used for generating ultra-long composite images, could produce alignment errors that the software failed to recognize. This occurred when external reference markers or measurement tools were not employed, and technicians relied solely on the automatic stitching feature. The company noted that these errors could, however, be identified and rectified through the "Manual Stitching" option.

To address this critical product issue affecting 14 countries and regions, Carestream implemented a multi-step corrective action plan. Customers were directly informed of the defect. Subsequently, the company's service personnel, Rayco, committed to conducting on-site inspections of the affected equipment. A free software upgrade package was to be installed to permanently resolve the stitching malfunction. In the interim, Carestream advised users to temporarily disable the problematic "Automatic Stitching" function and instead utilize the "Manual Stitching" editor for creating and compositing ultra-long images until the software upgrade installation was completed. This proactive recall aimed to ensure the accuracy and reliability of diagnostic imaging.

Company: https://www.globalkeysolutions.net/companies/carestream-health-inc/2a91c36d-2b8d-4dfd-951e-ebe539437f4c/