Reported Dec 24, 2014 · Terminated
CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of…
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. · 1049 W Ridge Rd · Rochester, NY · 14615-2731
Is this the product you have?
- CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
- Lot codes and dates
- Software Verions
1) 5.7.312.272) 5.7.312.273) 5.7.312.2031
- Software Verions
- Amount recalled
- 59 units
Where it was sold
Why it was recalled
Reduced mammographic image quality when attempting to print true size multi-format images
This product could cause temporary or reversible health problems — stop using it.
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