Recall Z-2449-2015— Carestream Health Inc

Name: FDA recall Z-2449-2015
Creator: U.S. Food and Drug Administration
Published: 2015-08-07

Class II · Terminated

Class II FDA medical device recall by Carestream Health Inc, initiated 2015-08-07, terminated 2016-07-06. It names one FDA 510(k) clearance: K141837. Product: CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a permanently installed diagnostic X-ray system for general radiographic x-ray imaging including tomography. The tomography feature is not to be used for imaging pediatric patients.. Reason: Software defect that impacts image alignment when using the automatic stitching option for long length images. The defect could cause stitching inconsistencies which may go undetected on a radiograph..

Recalling firm: Carestream Health Inc
Classification: Class II
Status: Terminated
Initiated: 2015-08-07
Terminated: 2016-07-06
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K141837 — DRX-EVOLUTIONCarestream Health, Inc.·cleared 2015-03-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a permanently installed diagnostic X-ray system for general radiographic x-ray imaging including tomography. The tomography feature is not to be used for imaging pediatric patients.

Reason for recall

Software defect that impacts image alignment when using the automatic stitching option for long length images. The defect could cause stitching inconsistencies which may go undetected on a radiograph.

Data sourced from openFDA. This site is unofficial and independent of the FDA.