Hologic Selenia Dimensions Mammography System Recalled for C-Arm Defects
Hologic is recalling 72 Selenia Dimensions Mammography Systems because the C-arm may seize or drop during repairs and cleaning.
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 3/5 (High).
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 risk-of-harm product (medical device) where the C-arm may drop, posing a potential injury risk, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Hologic, Inc. is recalling 72 units of the Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry. The recall is due to reports that the C-arm on the system may seize or drop during field repairs and cleaning of the systems.
The affected units were distributed domestically to 14 states, including Alaska, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Massachusetts, Missouri, North Carolina, New Hampshire, New Jersey, New York, Ohio, South Dakota, Texas, and Virginia. The units were also distributed to foreign countries including Italy, the United Kingdom, Saudi Arabia, Brazil, Costa Rica, Spain, Canada, Cyprus, Germany, France, Korea, Kuwait, The Netherlands, Oman, Peru, and Russia.
Healthcare facilities should contact Hologic, Inc. for further instructions regarding the recall and corrective actions for the affected serial numbers.
The recalled product
- Product
- Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636,
- Manufacturer
- Hologic, Inc.
- Affected units
- 72
Distribution
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