Hologic I-View Contrast Enhanced Digital Mammography System Recall
Hologic is recalling 337 I-View Contrast Enhanced Digital Mammography systems due to a calibration issue that prevents visualization of contrast uptake.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a functional defect (calibration issue) preventing image visualization, which is a significant quality issue but does not explicitly report injuries or deaths, fitting the Moderate criteria for non-critical functional defects.
Plain-English summary
Hologic, Inc. is recalling 337 units of the I-View Contrast Enhanced Digital Mammography system, model number ASY-08109. The recall is due to a calibration issue that makes it impossible to visualize contrast uptake in the subtracted mammography images.
The affected units were distributed nationwide and in numerous foreign countries, including Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Ecuador, Egypt, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Republic of, Kuwait, Malaysia, Mexico, Netherlands, Pakistan, Peru, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, and the United Kingdom.
The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice itself.
The recalled product
- Product
- I-View¿ Contrast Enhanced Digital Mammography, ASY-08109
- Manufacturer
- Hologic, Inc.
- Affected units
- 337
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)
- Model Number: ASY-08109 UDI Number: 15420045512016 All units
Distribution
Distributed nationwide across the United States.
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