Reported May 11, 2016 · Terminated
CARESTREAM Image Suite V4; Image Suite V4: DICOM STORE SCP: REF/Catalog # 1056191, DICOM STORE SCP/FOR IMAGE SUITE V4:…
Carestream Health Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Carestream Health Inc · 150 Verona St · Rochester, NY · 14608-1733
Is this the product you have?
- CARESTREAM Image Suite V4
- Image Suite V4DICOM
- STORE SCPREF/Catalog # 1056191
- DICOM STORE SCP/FOR IMAGE SUITE V4REF/Catalog # 6566988
- Image Suite V4 BundlesIMAGESUITE
- STANDALONE PACSREF/Catalog # 1741289
- IMAGESUITE STANDALONE PACS FOR INDIAREF/Catalog # 1741297
- Carestream PRO (Image Suite V4)PRO
- Medical Wireless GOS System-DesktopREF/Catalog # 1741891
- PRO Wireless System LaptopREF/Catalog # 1741925
- PRO Wireless System - w/o ComputerREF/Catalog # 1741933
- PRO Tethered System DesktopREF/Catalog # 1741941
- PRO Tethered System LaptopREF/Catalog # 1741958
- PRO Tether System - w/o ComputerREF/Catalog # 1741966
- PRO Fixed System - w/o ComputerREF/Catalog # 1741974
- PRO Medical Wireless CsI System-DesktopREF/Catalog # 1741982
- PRO Wireless System LaptopREF/Catalog # 1742006
- PRO Wireless System - w/o ComputerREF/Catalog # 1742014
- PRO Tethered System DesktopREF/Catalog # 1742022
- PRO Tethered System LaptopREF/Catalog # 1742055
- PRO Tether System - w/o ComputerCatalog # 1742063
- PRO Fixed System - w/o ComputerREF/Catalog # 1742089 -- Made in U.S.A
- byCarestream Health, Inc., 150 Verona Street, Rochester
- NY 14608 --- CLASSIFICATION NAMESystem, 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
- Lot codes and dates
- Equipment ID Numbers for US units
54842754548416695484242085013694548424115484087554841972548419738501762585017625580005598501323364821245484111154842348548421975484227652412604474418858501362485013511850137108501271854842406548435085241714--
- Equipment ID Numbers for Foreign UnitsPlease contact CDRH Recall Group for list of affected Equipment ID Numbers
- Equipment ID Numbers for US units
- Amount recalled
- US: 37 units, Foreign: 269 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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)".
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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