Carestream DRX-Revolution Mobile X-Ray System -- Made in U.S.A. by Carestream Health Inc. 150 Verona Street, Rochester,

FDA device recall Z-0491-2014 · posted 2014-01-03 · Terminated

Recall details

Recalling firm

Carestream Health Inc.

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.

Action taken

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

Status

Terminated

Product code

IZL

Quantity affected

310 systerms domestically

Distribution

Nationwide

Date initiated

2013-08-29

Date posted

2014-01-03

Date terminated

2015-11-18

Location

Rochester, NY