Company: Carestream Health, Inc.
Date of Enforcement Report 5/11/2016
Class lI:

PRODUCT

CARESTREAM Image Suite V3: MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490; MINI-PACS/F IMG ST/POC&VITA: REF/Catalog # 1036508; MINI-PACS/F IMG ST/CLASSIC/INDIA: REF/Catalog # 1036417; MINI-PACS/F IMG ST/ POC&VITA /INDIA: REF/Catalog # 1036425 — Made in USA by: Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608 — CLASSIFICATION NAME: System, Image Processing, Radiological The Carestream Image Suite System is an image management system whose intended use is to receive, process, review, display, print and archive images and data from CR and DR modalities. This excludes mammography applications in the United States.
Recall Number Z-1593-2016

REASON
Carestream Health received a complaint related to CARESTREAM Image Suite 4 from a foreign hospital stating that the annotation on the overlay is displayed as “L (Left)”, when it should be “R(Right)”.

RECALLING FIRM/MANUFACTURER
Carestream Health, Inc.,Rochester, NY on 4/15/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
US: 50 units; Foreign: 2499 units

DISTRIBUTION
Nationwide and Internationally

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