Print-ready dossier — use your browser's print dialog to save as PDF.
3Dimensions
Model 3DM-SYS-INTL2D-NS · Hologic, Inc. · DI 15420045510586
OTE — Digital Breast Tomosynthesis · Class III
UDILibrary device dossier · generated 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (1)
Initiated
Recall #
Class
Status
Reason
Link basis
2026-04-08
Z-2168-2026
Class II
Open, Classified
Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
code info di
Adverse-event reports — MAUDE (0)
Caveat (required reading): 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 is a reporting baseline (average device in the same product code), not a risk measure.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
2
2019-02
0
2
2019-04
0
2
2019-05
0
3
2019-06
0
2
2019-07
0
2
2019-08
0
2
2019-09
0
2
2019-11
0
3
2019-12
0
2
2020-01
0
2
2020-02
0
2.67
2020-03
0
2
2020-06
0
2
2020-07
0
2
2020-08
0
2
2020-09
0
2
2020-12
0
2
2021-02
0
2
2021-05
0
2
2021-07
0
2
2021-08
0
2
2021-09
0
4
2021-11
0
4
2021-12
0
2
2022-02
0
2
2022-03
0
4.33
2022-04
0
3
2022-05
0
1.5
2022-06
0
3
2022-08
0
6
2022-09
0
3
2022-10
0
2.5
2022-11
0
3.5
2022-12
0
3
2023-01
0
3
2023-02
0
2
2023-03
0
3.33
2023-04
0
2
2023-06
0
2
2023-08
0
1.5
2023-09
0
2
2023-10
0
2
2023-11
0
5
2023-12
0
4
2024-01
0
1.5
2024-02
0
7
2024-03
0
5.5
2024-04
0
3.5
2024-05
0
5
2024-06
0
5.5
2024-07
0
5.67
2024-08
0
6.33
2024-09
0
4.5
2024-10
0
2.5
2024-11
0
6.25
2024-12
0
4
2025-01
0
2
2025-02
0
3
2025-03
0
4
2025-04
0
7.75
2025-05
0
16
2025-06
0
4.2
2025-07
0
10
2025-08
0
3.33
2025-09
0
6.33
2025-10
0
3.75
2025-11
0
3.75
2025-12
0
4.25
2026-01
0
4
2026-02
0
7.33
2026-03
0
7
2026-04
0
6.5
2026-05
0
5.29
2026-06
0
8.75
This device (reports/month)Average device in OTE (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Hologic, Inc.
Warning Letter 2024-12-18 Hologic, Inc
Warning Letter 2024-12-18 Hologic, Inc
OAI 2025-11-04 Hologic, Inc · 3 citations
OAI 2025-11-04 Hologic, Inc · 3 citations
OAI 2024-09-24 Hologic, Inc · 5 citations
OAI 2024-09-24 Hologic, Inc · 5 citations
VAI 2024-09-12 Hologic Surgical Products Costa Rica, S.R.L. · 0 citations