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DRX Revolution Mobile X-Ray System, Model DRXR-1, Verona… recallZ-0090-2014 · Carestream Health, Inc. · initiated Jul 26, 2013

Class II Terminated All recalls posted in October 2013

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Carestream Health, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Software design

What the company is doing

Carestream sent a Urgent-Medical Device Recall letter dated July 26, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Carestream Health Inc. recently discovered an image artifact issue due to a detector not being recalibrated with the 5.6B software upgrade. As our installation instructions did not require the user to recalibrate during an upgrade, there is a possibility your detector could do the same. When this occurs an image artifact could be evident on images captured in the Extended Exposure mode. These artifacts could potentially contribute to misdiagnosis or the necessity of patient re-exposure. We request that you take a moment to verify that your detector(s) are calibrated. At our next visit, Carestream will also verify that your detector was re-calibrated and, if not, re-calibrate the detector for you. Please note this only affects systems upgraded in the field. For questions or concerns, please contact the Carestream Customer Care Center at 1-800-328-2910, 8 am through 8 pm EST in the US.

Recall details

Recall number
Z-0090-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Jul 26, 2013
Posted by the FDA
Oct 31, 2013
Recalling firm
Carestream Health, Inc.
Quantity
23 units installed total (11 domestically & 12 internationally)
Product code
IZL
FDA submissions
K120062
Distribution
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.

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.

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

1 device cleared under K120062 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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