Selenia Full Field Digital Mammography System with recall: Software Issue
Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x The Selenia Full Field Digital Mammography system generates…
Why was Selenia Full Field Digital Mammography System with recalled?
Software: When the Selenia upon meeting the hard drive threshold of 4,000 images, may delete the most recently dated images
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Software versions 5.0.x and 5.1.x
- Product
- Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x The Selenia Full Field Digital Mammography system generates…
- Recalling firm
- Hologic, Inc.
- Quantity
- 62 systems
- Distribution
- Worldwide Distribution - USA including the states of AL, AR, CA, CO, FL, IL, KY, LA, NE, NC, NJ, NY, OH, PA, TN, TX, UT, WA and WV., and the countries of Canada, Denmark, Iran, Italy, Mexico and Taiwan.
- Recall date
- October 9, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)