Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
1 linked reportInjury 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 6 |
| 2019-02 | 0 | 2.5 |
| 2019-03 | 0 | 4.5 |
| 2019-04 | 0 | 7 |
| 2019-05 | 0 | 4 |
| 2019-06 | 0 | 4 |
| 2019-07 | 0 | 3.5 |
| 2019-08 | 0 | 4.5 |
| 2019-09 | 0 | 3 |
| 2019-11 | 0 | 9 |
| 2019-12 | 0 | 3 |
| 2020-01 | 0 | 3 |
| 2020-02 | 0 | 3.67 |
| 2020-09 | 0 | 3 |
| 2021-02 | 0 | 1 |
| 2021-05 | 0 | 3 |
| 2021-09 | 0 | 3.5 |
| 2021-11 | 0 | 2 |
| 2022-01 | 0 | 2 |
| 2022-09 | 0 | 1 |
| 2022-10 | 0 | 1 |
| 2023-01 | 0 | 4 |
| 2023-02 | 0 | 2.5 |
| 2023-06 | 0 | 3 |
| 2024-02 | 0 | 3 |
| 2024-04 | 0 | 3 |
| 2024-08 | 0 | 3 |
| 2024-09 | 1 | 1 |
| 2025-02 | 0 | 2 |
| 2025-04 | 0 | 2.5 |
| 2025-08 | 0 | 2 |
| 2025-09 | 0 | 6 |
| 2025-10 | 0 | 9 |
| 2025-11 | 0 | 4.5 |
| 2025-12 | 0 | 3 |
| 2026-01 | 0 | 4 |
| 2026-02 | 0 | 6 |
| 2026-03 | 0 | 5.5 |
| 2026-04 | 0 | 2 |
| 2026-05 | 0 | 2 |
| 2026-06 | 0 | 3 |
Failure-mode summaryAI-generated
1 linked report narrative available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2012-07-02 | Z-2080-2012 | Class II | Terminated | Imaging artifact can occur on mammogram resultDistribution: International Distribution including Nationwide(USA), and the countries of Japan and Canada. | 86,000 units | clearance family |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2024-09-19 | 9021987-2024-00003 | Injury | Available | exact di |
Regulatory clearances
Predicate lineage
K073262
Cited as predicate by: K161920
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2025-04-09 | NAI | No action indicated | Beekley Corporation | 0 |
| 2025-04-09 | NAI | No action indicated | Beekley Corporation | 0 |
| 2018-09-19 | VAI | Voluntary action indicated | Beekley Corporation | 1 |
| 2018-09-19 | VAI | Voluntary action indicated | Beekley Corporation | 1 |
| 2015-04-28 | VAI | Voluntary action indicated | Beekley Corporation | 1 |
| 2015-04-28 | VAI | Voluntary action indicated | Beekley Corporation | 1 |
| 2012-11-16 | VAI | Voluntary action indicated | Beekley Corporation | 0 |
| 2012-11-16 | VAI | Voluntary action indicated | Beekley Corporation | 0 |
| 2012-06-11 | WL | Warning Letter | Beekley Corporation | — |
| 2012-06-11 | WL | Warning Letter | Beekley Corporation | — |
| 2012-05-03 | OAI | Official action indicated | Beekley Corporation | 8 |
| 2012-05-03 | OAI | Official action indicated | Beekley Corporation | 8 |
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