Class II — Hologic, Inc.
| Recalling firm | HOLOGIC, INC. |
|---|---|
| Registered facility | View this company's 12 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The recalling firm has received reports from the field of the C-arm on the Selenia Dimensions system seizing or dropping during field repairs and cleaning of the systems. |
| Product | Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636, |
| Quantity | 72 |
| Distribution | Domestic distribution to 14 states: AK AZ CA CO CT DC FL GA IA ID IL MA MO NC NH NJ NY OH SD TX VA. Foreign distribution to Italy, United Kingdom, Saudi Arabia, Brazil, Costa Rica, Spain, Canada, Cyprus, Germany, France, Korea, Kuwait, The Netherlands, Oman, Peru, and Russia. |
| Initiated | 2020-01-21 |
| Classified | 2020-02-21 |
| Terminated | 2021-08-11 |
| Recall number | Z-1343-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Hologic, Inc. (Z-1343-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84882/
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