Recall Z-0844-2014— Carestream Health, Inc.

Name: FDA recall Z-0844-2014
Creator: U.S. Food and Drug Administration
Published: 2013-12-26

Class II · Terminated

Class II FDA medical device recall by Carestream Health, Inc., initiated 2013-12-26, terminated 2017-03-10. It names one FDA 510(k) clearance: K051258. Product: KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream Health, Inc. Made in U.S.A.. Reason: Carestream Health, Inc. has recalled DR 7500 Dual Detector System utilizing Version 5.X Software due to a possible patient image display error..

Recalling firm: Carestream Health, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-12-26
Terminated: 2017-03-10
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K051258 — KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345Eastman Kodak Company·cleared 2005-06-01

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

KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream Health, Inc. Made in U.S.A.

Reason for recall

Carestream Health, Inc. has recalled DR 7500 Dual Detector System utilizing Version 5.X Software due to a possible patient image display error.

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