MAUDE manufacturer profile
HOLOGIC, INC · IZH
MAUDE profile for System, X-Ray, Mammographic
Key facts
| Manufacturer | HOLOGIC, INC |
|---|---|
| Manufacturer group | HOLOGIC, INC |
| Product code | IZH |
| Product code name | System, X-Ray, Mammographic |
At a glance
- 100–999 MAUDE reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Consequences Or Impact To Patient, Unintended System Motion, No Clinical Signs, Symptoms or Conditions, Not Applicable, Imprecision, No Known Impact Or Consequence To Patient, Adverse Event Without Identified Device or Use Problem, Use of Device Problem Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE manufacturer and product code profiles
Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1