DRX Revolution Mobile X-Ray System, Model DRXR-1, Verona Street Rochester, NY 14608 Catalog Numbers 1019397, 1023415, 1023423 --- Made in USA by Carestream Health, Inc. 150 The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas.

Reason: During an audit, Carestream discovered a DRX-1 System that captured an image which displayed an artifact. This issue was discovered in manufacturing. It occurs when the DRX product console software is updated to v5.6b software and the detector is not calibrated before use.

Code information: Serial numbers: U.S. - 134,152,173,174,200,205,222,312,349,353,412, Worldwide Serial numbers: 469, 445, 306, 410, 453, 204, 483, 300, 171, 218

Distribution pattern: Worldwide Distribution - US (nationwide) including the states of New York, Massachusetts, Pennsylvania, Illinois, Texas, California and Louisiana., and the countries of Australia, Canada, Finland, Italy, Switzerland and United Kingdom.