DRX Revolution Mobile X-Ray System, Model DRXR-1, Verona Street Rochester, NY 14608 Catalog Numbers 1019397, 1023415, 10
FDA device recall Z-0090-2014 · posted 2013-10-31 · Terminated
Recall details
- Recalling firm
- Carestream Health, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IZL
- Quantity affected
- 23 units installed total (11 domestically & 12 internationally)
- 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, Ita
- Date initiated
- 2013-07-26
- Date posted
- 2013-10-31
- Date terminated
- 2016-05-25
- Location
- Rochester, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DRX-REVOLUTION MOBILE X-RAY SYSTEM (K120062) | Carestream Health, Inc. | 2012-04-13 |