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.
2 linked reportsMalfunction 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2 |
| 2019-02 | 2 | 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 |
Failure-mode summaryAI-generated
2 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2025-06-11 | Z-2219-2025 | Class II | Open, Classified | Devices had an unapproved slabbing software function enabled for use.Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Chile, Ecuador. | 293 units | clearance family |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2019-02-28 | 3001722928-2019-00001 | Malfunction | Available | procode brand trgm |
| 2019-02-28 | 1000513161-2019-00001 | Malfunction | Available | procode brand trgm |
Regulatory clearances
- PMAP160031Approved (APPR) · 2023-02-13 · +4 earlier decisionsclearance family
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2025-03-26 | VAI | Voluntary action indicated | FUJIFILM MEDWORK GMBH | 1 |
| 2023-09-22 | VAI | Voluntary action indicated | Fujifilm Corporation | 3 |
| 2023-09-22 | VAI | Voluntary action indicated | Fujifilm Corporation | 3 |
| 2023-03-10 | VAI | Voluntary action indicated | FUJIFILM Healthcare Manufacturing Corp. | 0 |
| 2023-01-27 | VAI | Voluntary action indicated | FUJIFILM Healthcare Manufacturing Corporation Sano Office | 2 |
| 2019-09-30 | OAI | Official action indicated | Fujifilm Corporation | 0 |
| 2019-09-30 | OAI | Official action indicated | Fujifilm Corporation | 0 |
| 2019-09-10 | OAI | Official action indicated | FUJIFILM Healthcare Manufacturing Corporation Sano Office | 0 |
| 2019-06-21 | VAI | Voluntary action indicated | FUJIFILM Healthcare Americas Corporation | 2 |
| 2018-07-13 | VAI | Voluntary action indicated | Fujifilm Corporation | 1 |
| 2018-07-13 | VAI | Voluntary action indicated | Fujifilm Corporation | 1 |
| 2018-03-29 | VAI | Voluntary action indicated | FUJIFILM Healthcare Americas Corporation | 1 |
| 2018-03-09 | WL | Warning Letter | Fujifilm Corporation | — |
| 2018-03-09 | WL | Warning Letter | Fujifilm Corporation | — |
| 2017-12-21 | VAI | Voluntary action indicated | FUJIFILM Corporation Medical Systems Research & Development Center Kashiwa | 0 |
| 2017-11-08 | NAI | No action indicated | FUJIFILM Healthcare Americas Corporation | 0 |
| 2016-11-10 | NAI | No action indicated | FUJIFILM Healthcare Americas Corporation | 0 |
| 2016-10-31 | NAI | No action indicated | FUJIFILM Healthcare Americas Corporation | 0 |
| 2015-04-22 | OAI | Official action indicated | FUJIFILM Healthcare Manufacturing Corporation Sano Office | 7 |
| 2015-02-19 | VAI | Voluntary action indicated | FUJIFILM Healthcare Americas Corporation | 2 |
| 2014-02-19 | NAI | No action indicated | FUJIFILM Healthcare Manufacturing Corp. | 0 |
| 2013-04-25 | NAI | No action indicated | Fujifilm Corporation | 0 |
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