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Terminated

Carestream DRX-Revolution Mobile X-Ray System -- Made in U.S.A. by Carestream Health Inc. 150 Verona Street, Rochester, NY . 14608 --- The DRX Revolution Mobile system is a mobile diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. These products are mobile diagnostic x-ray systems designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas.

FDA Recall Z-0491-2014 · Posted 2014-01-03

Recall StatusTerminated
Product CodeIZL
Date Initiated2013-08-29
Date Terminated2015-11-18
Product Quantity310 systerms domestically

Reason for Recall

It was discovered that Carestream received a report from a customer that 2 different patients were re-exposed due to the fact that the processed images were not able to be found in the system.

Firm Action

Carestream sent a letter to all affected customers informing them of the issue, how to detect the issue and actions to be taken by Carestream to correct the issue. The actions to be taken by Carestreamn to correct the issue will include the installation of a software patch to mitigate the effects of the observed failure and remove the possibility of a re-exposure in this failure mode. The correction will be implemented within the US to all affected devices at identified customer sites. For further questions call Carestream Customer Care at 1-800-328-2910, 8 am through 8 pm Eastern Standard Time.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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