FDA-Device2015-09-02Class II
CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a permanently installed diagnostic X-ray system for general radiographic x-ray imaging including tomography. The tomography feature is not to be used for imaging pediatric patients.
Carestream Health Inc
Hazard
Software defect that impacts image alignment when using the automatic stitching option for long length images. The defect could cause stitching inconsistencies which may go undetected on a radiograph.
Sold states
Worldwide Distribution - US Nationwide and in the countries: Australia, Canada, Chile, China, India, Korea, Malaysia, New Zealand, Singapore, Switzerland, Taiwan and Thailand.
Affected count
Domestic: 76 units, Foreign: 160 units
Manufactured in
150 Verona St, N/A, Rochester, NY, United States
Products
CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a permanently installed diagnostic X-ray system for general radiographic x-ray imaging including tomography. The tomography feature is not to be used for imaging pediatric patients.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2449-2015Don't want to check this manually?
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