Carestream—DRX-Evolution Digital Radiography Systems with DR LLI Auto Stitch Option and DirectView Software: Auto Stitch May Be Incorrect on Long Length Imaging

August 19, 2015 | Risk Management News

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ECRI Institute's complete weekly summary of medical device hazard and recall information is available in ECRI Institute's Health Devices Alerts(HDA). For more information about HDA, contact us at clientservices@ecri.org.

In a July 29, 2015, Urgent Medical Device Correction letter  submitted by an ECRI Institute member hospital and an August 3, 2015, Urgent Field Safety Notice letter posted by the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA), Carestream states that a software defect in the systems below may affect image alignment when the automatic stitching option for long length images (LLI) is used. If there is no use of external fiducial markers or measurement tools (i.e. radio opaque ruler) when building a composite image and the user relies only on the auto stitching software, there may be a risk of undetected stitching error that would otherwise be noticed and corrected with the use of manual stitching. The manufacturer has not confirmed the...

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