RecallRadar

FDA Device recall Z-1594-2016

CARESTREAM Image Suite V4

On 2016-05-11 the FDA classified a Class II recall of CARESTREAM Image Suite V4 by Carestream Health, citing 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 s….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1594-2016
ClassificationClass II
Statusterminated
Initiated2016-04-15
Published2016-05-11
Last updated2026-09-13 11:54 UTC
CompanyCarestream Health
DistributionUS

Product

CARESTREAM Image Suite V4; Image Suite V4: DICOM STORE SCP: REF/Catalog # 1056191, DICOM STORE SCP/FOR IMAGE SUITE V4: REF/Catalog # 6566988; Image Suite V4 Bundles: IMAGESUITE STANDALONE PACS: REF/Catalog # 1741289, IMAGESUITE STANDALONE PACS FOR INDIA: REF/Catalog # 1741297; Carestream PRO (Image Suite V4): PRO Medical Wireless GOS System-Desktop: REF/Catalog # 1741891, PRO Wireless System Laptop: REF/Catalog # 1741925, PRO Wireless System - w/o Computer: REF/Catalog # 1741933, PRO Tethered System Desktop: REF/Catalog # 1741941, PRO Tethered System Laptop: REF/Catalog # 1741958, PRO Tether System - w/o Computer: REF/Catalog # 1741966, PRO Fixed System - w/o Computer: REF/Catalog # 1741974, PRO Medical Wireless CsI System-Desktop: REF/Catalog # 1741982, PRO Wireless System Laptop: REF/Catalog # 1742006, PRO Wireless System - w/o Computer: REF/Catalog # 1742014, PRO Tethered System Desktop: REF/Catalog # 1742022, PRO Tethered System Laptop: REF/Catalog # 1742055, PRO Tether System - w/o Computer: Catalog # 1742063; PRO Fixed System - w/o Computer: REF/Catalog # 1742089 -- Made in U.S.A. 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

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)".

Identifiers

code_info
Equipment ID Numbers for US units: 54842754, 54841669, 54842420, 85013694, 54842411, 54840875, 54841972, 54841973, 850…Equipment ID Numbers for US units: 54842754, 54841669, 54842420, 85013694, 54842411, 54840875, 54841972, 54841973, 85017625, 85017625, 58000559, 85013233, 6482124, 54841111, 54842348, 54842197, 54842276, 52412604, 47441885, 85013624, 85013511, 85013710, 85012718, 54842406, 54843508, 5241714; -- Equipment ID Numbers for Foreign Units: Please contact CDRH Recall Group for list of affected Equipment ID Numbers.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Other recalls by Carestream Health

All Carestream Health recalls

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1594-2016%22

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