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.
347 linked reportsMalfunction 328Injury 19
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2 |
| 2019-02 | 0 | 2 |
| 2019-04 | 2 | 2 |
| 2019-05 | 0 | 3 |
| 2019-06 | 0 | 2 |
| 2019-07 | 0 | 2 |
| 2019-08 | 0 | 2 |
| 2019-09 | 2 | 2 |
| 2019-11 | 0 | 3 |
| 2019-12 | 2 | 2 |
| 2020-01 | 0 | 2 |
| 2020-02 | 2 | 2.67 |
| 2020-03 | 2 | 2 |
| 2020-06 | 0 | 2 |
| 2020-07 | 2 | 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 | 2 | 2 |
| 2021-09 | 0 | 4 |
| 2021-11 | 4 | 4 |
| 2021-12 | 2 | 2 |
| 2022-02 | 2 | 2 |
| 2022-03 | 9 | 4.33 |
| 2022-04 | 3 | 3 |
| 2022-05 | 2 | 1.5 |
| 2022-06 | 3 | 3 |
| 2022-08 | 6 | 6 |
| 2022-09 | 3 | 3 |
| 2022-10 | 3 | 2.5 |
| 2022-11 | 0 | 3.5 |
| 2022-12 | 0 | 3 |
| 2023-01 | 0 | 3 |
| 2023-02 | 0 | 2 |
| 2023-03 | 2 | 3.33 |
| 2023-04 | 4 | 2 |
| 2023-06 | 2 | 2 |
| 2023-08 | 0 | 1.5 |
| 2023-09 | 2 | 2 |
| 2023-10 | 0 | 2 |
| 2023-11 | 5 | 5 |
| 2023-12 | 5 | 4 |
| 2024-01 | 2 | 1.5 |
| 2024-02 | 8 | 7 |
| 2024-03 | 8 | 5.5 |
| 2024-04 | 6 | 3.5 |
| 2024-05 | 9 | 5 |
| 2024-06 | 15 | 5.5 |
| 2024-07 | 10 | 5.67 |
| 2024-08 | 5 | 6.33 |
| 2024-09 | 9 | 4.5 |
| 2024-10 | 3 | 2.5 |
| 2024-11 | 8 | 6.25 |
| 2024-12 | 4 | 4 |
| 2025-01 | 2 | 2 |
| 2025-02 | 5 | 3 |
| 2025-03 | 4 | 4 |
| 2025-04 | 21 | 7.75 |
| 2025-05 | 16 | 16 |
| 2025-06 | 7 | 4.2 |
| 2025-07 | 13 | 10 |
| 2025-08 | 0 | 3.33 |
| 2025-09 | 10 | 6.33 |
| 2025-10 | 8 | 3.75 |
| 2025-11 | 5 | 3.75 |
| 2025-12 | 11 | 4.25 |
| 2026-01 | 4 | 4 |
| 2026-02 | 16 | 7.33 |
| 2026-03 | 12 | 7 |
| 2026-04 | 14 | 6.5 |
| 2026-05 | 22 | 5.29 |
| 2026-06 | 19 | 8.75 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | 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.Distribution: US Nationwide distribution. | 14837 units | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-06-26 | 3005496266-2026-00168 | Malfunction | — | catalog number |
| 2026-06-17 | 3005496266-2026-00158 | Malfunction | Available | catalog number |
| 2026-06-12 | 3005496266-2026-00154 | Malfunction | Available | catalog number |
| 2026-06-12 | 3005496266-2026-00152 | Malfunction | Available | catalog number |
| 2026-06-12 | 3005496266-2026-00149 | Malfunction | Available | catalog number |
| 2026-06-10 | 3005496266-2026-00146 | Malfunction | Available | catalog number |
| 2026-06-10 | 3005496266-2026-00145 | Malfunction | Available | catalog number |
| 2026-06-10 | MW5189208 | Malfunction | Available | model number |
| 2026-06-05 | 3005496266-2026-00142 | Malfunction | Available | catalog number |
| 2026-06-05 | 3005496266-2026-00141 | Malfunction | Available | catalog number |
| 2026-05-31 | 3005496266-2026-00132 | Malfunction | Available | catalog number |
| 2026-05-26 | 3005496266-2026-00122 | Malfunction | Available | catalog number |
| 2026-05-22 | 3005496266-2026-00116 | Malfunction | Available | catalog number |
| 2026-05-22 | 3005496266-2026-00114 | Malfunction | Available | catalog number |
| 2026-05-17 | 3005496266-2026-00111 | Malfunction | Available | catalog number |
Showing the most recent 150 of 347 linked reports.
Showing 1–15 of 150
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2025-11-04 | OAI | Official action indicated | Hologic, Inc | 3 |
| 2025-11-04 | OAI | Official action indicated | Hologic, Inc | 3 |
| 2024-12-18 | WL | Warning Letter | Hologic, Inc | — |
| 2024-12-18 | WL | Warning Letter | Hologic, Inc | — |
| 2024-09-24 | OAI | Official action indicated | Hologic, Inc | 5 |
| 2024-09-24 | OAI | Official action indicated | Hologic, Inc | 5 |
| 2024-09-12 | VAI | Voluntary action indicated | Hologic Surgical Products Costa Rica, S.R.L. | 0 |
| 2024-08-13 | NAI | No action indicated | Hologic, Inc. | 0 |
| 2024-08-13 | NAI | No action indicated | Hologic, Inc. | 0 |
| 2022-12-14 | NAI | No action indicated | Bolder Surgical, LLC | 0 |
| 2022-10-14 | OAI | Official action indicated | Hologic, Inc. | 4 |
| 2022-10-14 | OAI | Official action indicated | Hologic, Inc. | 4 |
| 2022-08-03 | VAI | Voluntary action indicated | Health Beacons, Inc. | 1 |
| 2020-02-25 | NAI | No action indicated | Health Beacons, Inc. | 0 |
| 2018-12-10 | NAI | No action indicated | Hologic, Inc. | 0 |
| 2018-12-10 | NAI | No action indicated | Hologic, Inc. | 0 |
| 2018-02-27 | NAI | No action indicated | Gynesonics, Inc. | 0 |
| 2017-11-30 | NAI | No action indicated | Hologic, Inc | 0 |
| 2017-11-30 | NAI | No action indicated | Hologic, Inc | 0 |
| 2017-11-27 | VAI | Voluntary action indicated | Bolder Surgical, LLC | 6 |
| 2017-10-25 | NAI | No action indicated | Hologic, Inc. | 0 |
| 2017-10-25 | NAI | No action indicated | Hologic, Inc. | 0 |
Similar devices
- ASPIRE Cristalle Digital Breast Tomosynthesis Option FUJIFILM CORPORATION
- Not Applicable GE MEDICAL SYSTEMS
- SenoClaire GE MEDICAL SYSTEMS
- SenoClaire GE MEDICAL SYSTEMS
- Senographe Pristina GE MEDICAL SYSTEMS
- Senographe Pristina GE MEDICAL SYSTEMS
- Senographe Pristina 3D GE MEDICAL SYSTEMS
- Senographe Pristina 3D GE MEDICAL SYSTEMS
- Tomosynthesis option Siemens Healthcare GmbH
- not applicable GE MEDICAL SYSTEMS
- not applicable GE MEDICAL SYSTEMS
- not applicable GE MEDICAL SYSTEMS
Select up to two to place side-by-side with this device.