Carestream Health, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0090-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: July 26, 2013

Date Posted: November 6, 2013

Recall Number: Z-0090-2014

Event ID: 65805

Reason for Recall:

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.

Status: Terminated

Product Quantity: 23 units installed total (11 domestically & 12 internationally)

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.

Voluntary or Mandated:

Voluntary: Firm initiated