Full Field Digital, System, X-Ray, Mammographic
Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.
OpenFDA device adverse-event casebook.
FDA Class II (moderate risk, special controls required), regulated under 21 CFR §892.1715 (Radiology panel).
FDA MAUDE casebook
openFDA event book Full Field Digital LIGHT-BOOK · MAUDE
#796 of 1000 · 659 reports · 2008–2026
- BOOK 659 reports
- RANK #796 of 1000
- DEATH 5 death-typed
- INJ 53 injury-typed
- MALF 488 malfunction
- SPAN 2008–2026
- PEAK 2018: 144
- PHOTO Guide
Nearest event-volume peer: Guide, Wire, Catheter, Neurovasculature (2 report gap)
Full Field Digital, System, X-Ray, Mammographic sits #796 of 1000 among tracked device types with 659 MAUDE reports spanning 2008–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →
Injury-coded reports sit below the device-type norm
Full Field Digital carries 8.0% INJURY-coded reports, 22.3pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.8% corpus 1.5% · below corpus mean (-0.7 pp)
- INJ 8.0% corpus 30.3% · below corpus mean (-22.3 pp)
- MALF 74.1% corpus 64.8% · above corpus mean (+9.2 pp)
Lead product-problem code Unintended System Motion is 34% of coded problems · Lead manufacturer HOLOGIC, INC accounts for 53% of manufacturer-tagged reports · Top event location I is 48% of location-tagged rows .
Full Field Digital in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Accessories
Accessories, Cleaning Brushes, For Endoscope
664 reports
- Instrument
Instrument, Coagulation, Automated
661 reports
- Full Field Di… (this)
Full Field Digital, System, X-Ray, Mammographic
659 reports
- Guide
Guide, Wire, Catheter, Neurovasculature
657 reports
- Instruments
Instruments, Dental Hand
656 reports
- Instrument Fo…
Instrument For Treatment Of Hyperhidrosis
655 reports
What this shows Full Field Digital, System, X-Ray, Mammographic carries 659 MAUDE reports, ranked #796 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports in 2025 (40) held close to the prior two-year average of 31.
Related Entities for Full Field Digital, System, X-Ray, Mammographic
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Full Field Digital: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (659 here).
Similar death-typed counts
Nearest other device types by death-typed report count (5 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Full Field Digital are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.
Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Full Field Digital; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.