CARESTREAM Image Suite V4 — Class II medical device recall Z-1594-2016
Terminated recall by Carestream Health Inc, reported 2016-05-11, distributed nationwide. Carestream Health received a complaint related to CARESTREAM Image Suite 4 from a foreign hospital stating tha
| Recall number | Z-1594-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carestream Health Inc, Rochester, NY, United States |
| Recall initiated | 2016-04-15 |
| Classified | 2016-05-02 |
| Reported by FDA | 2016-05-11 |
| Terminated | 2017-03-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AF, AR, AT, AU, BD, BE, BG, BH, BR, CA, CL, CN, CO, CZ, DE, ES, FR, GB, GR, HR, HU, ID, IE, IN, IQ, IR, IT, JM, JO, JP, KR, KW, LB, LK, LT, LV, MX, MY, NL, NO, NP, NZ, OM, PE, PH, PL, PT, RO, RS, RU, SA, SG, SK, TH, TW, UY, VN, ZA |
| Model numbers | 1056191, 1741289, 1741297, 1741891, 1741925, 1741933, 1741941, 1741958, 1741966, 1741974, 1741982, 1742006, 1742014, 1742022, 1742055, 1742063, 1742089, 6566988 |
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 for recall
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)".
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.