Hologic Selenia Mammography System Software Recall for Image Deletion
Hologic is recalling 62 Selenia Full Field Digital Mammography Systems because software versions 5.0.x and 5.1.x may delete recent images when the hard drive reaches a 4,000-image threshold.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device used for cancer diagnosis where a software defect can lead to the loss of critical diagnostic data. This fits the rubric for 'risk-of-harm products where injury has not yet been reported' as the loss of images could impact patient care, though no specific injuries are cited in the source.
Plain-English summary
Hologic, Inc. is recalling 62 Selenia Full Field Digital Mammography Systems equipped with software versions 5.0.x and 5.1.x. The recall is due to a software defect where the system may delete the most recently dated images when the hard drive reaches a threshold of 4,000 images.
The affected systems are distributed worldwide, including in the United States (specifically in AL, AR, CA, CO, FL, IL, KY, LA, NE, NC, NJ, NY, OH, PA, TN, TX, UT, WA, and WV) and in Canada, Denmark, Iran, Italy, Mexico, and Taiwan. These systems are used to generate digital mammography images for the screening and diagnosis of breast cancer.
Healthcare facilities should contact Hologic for instructions on how to resolve the software issue to prevent the loss of diagnostic images.
The recalled product
- 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 digital mammography images that can be used for screening and diagnosis of breast cancer. The Selenia Full Field Digital Mammography
- Manufacturer
- Hologic, Inc.
- Hazard
- Affected units
- 62
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Software versions 5.0.x and 5.1.x
Distribution
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