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.
No adverse-event reports are linked to this device.
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 |
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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