Recall Z-1877-2013— Carestream Health Inc.

Name: FDA recall Z-1877-2013
Creator: U.S. Food and Drug Administration
Published: 2013-06-03

Class II · Terminated

Class II FDA medical device recall by Carestream Health Inc., initiated 2013-06-03, terminated 2014-01-29. It names one FDA 510(k) clearance: K091889. Product: Carestream DRX Evolution System, X-Ray System --- The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.. Reason: Due to potential for an x-ray exposure technique change..

Recalling firm: Carestream Health Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-06-03
Terminated: 2014-01-29
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K091889 — DRX-EVOLUTION, MODEL VX3733-SYSCarestream Health, Inc.·cleared 2009-07-20

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 System, X-Ray System --- The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.

Reason for recall

Due to potential for an x-ray exposure technique change.

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