Reported May 11, 2016 · Terminated
CARESTREAM Image Suite V3
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 V3
4 of 4 products
| Model / number | Product as published |
|---|---|
1036490 | MINI-PACS/F IMG ST/CLASSIC: REF/ |
1036508 | MINI-PACS/F IMG ST/POC&VITA: REF/ |
1036417 | MINI-PACS/F IMG ST/CLASSIC/INDIA: REF/ |
1036425 | MINI-PACS/F IMG ST/ POC&VITA /INDIA: REF/ -- 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. |
- Lot codes and dates
- Equipment ID NumbersUS
- units
8501-2596850188608501-09545241-25965241-25465241-27135296-344752414419524144555241-26405241-2716548385525483-85028501-46655240815885014687548391285483-92125241253952414661529628974745-39865241-2337850122628501-58988501-260254838630524126705296-34505296-34495483855452408157548386185241-454754842652524206758501-286152414685524147515484-308654838598524123675241441754839211548386164745-599152412243548426675241714952412340--
- Equipment ID Numbers for Foreign UnitsPlease contact CDRH Recall Group for list of affected Equipment ID Numbers
- Amount recalled
- US: 50 units; Foreign: 2499 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.
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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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