Reported Oct 9, 2013 · Terminated
Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x The Selenia Full Field Digital…
Hologic, 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: Hologic, Inc. · 36 Apple Ridge Rd # 37 · Danbury, CT · 06810-7301
Is this the product you have?
- Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer. The Selenia Full Field Digital Mammography System is intended for use in the same clinical applications as traditional screen-film mammography systems. Mammography images can be interpreted on either hard copy film or soft copy review workstations, cleared for mammography
- Lot codes and dates
- Software versions 5.0.x and 5.1.x
- Amount recalled
- 62 systems
Where it was sold
Why it was recalled
Software: When the Selenia upon meeting the hard drive threshold of 4,000 images, may delete the most recently dated images
This product could cause temporary or reversible health problems — stop using it.
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