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.
FDA Recall Z-2449-2015 · Posted 2015-08-22
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Recalling FirmCarestream Health Inc
Recall StatusTerminated
Product CodeKPR
Date Initiated2015-08-07
Date Terminated2016-07-06
Product QuantityDomestic: 76 units, Foreign: 160 units
Reason for Recall
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.
Firm Action
Carestream sent an Urgent Medical Device Correction letters dated July 29, 2015 and Customer Notification Acknowledgement Forms to customers via Certified Mail. The letter identified the affected product, problem and actions to be taken. Carestream will update the software on your device to correct this issue. For questions or concerns, contact the Carestream Customer Care Center in the U.S. at 1-800-328-2910, available 7 days per week on a 24 hour basis. Outside of the U.S., please call your local Service support number.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution - US Nationwide and in the countries: Australia, Canada, Chile, China, India, Korea, Malaysia, New Zealand, Singapore, Switzerland, Taiwan and Thailand.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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