Company: Carestream Health, Inc.
Date of Enforcement Report:2/5/2014
Class lI:
PRODUCT
KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608. Made in U.S.A.
Recall Number Z-0844-2014
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/MANUFACTURER
Carestream Health, Inc. Rochester, NY on 12/26/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
164 units
DISTRIBUTION
Nationwide and Internationally
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