MAUDE manufacturer profile
AGFA HEALTHCARE N.V. · LLZ
MAUDE profile for System, Image Processing, Radiological
Key facts
| Manufacturer | AGFA HEALTHCARE N.V. |
|---|---|
| Manufacturer group | AGFA HEALTHCARE N.V. |
| Product code | LLZ |
| Product code name | System, Image Processing, Radiological |
At a glance
- 1,000+ MAUDE reports
- 1–9 Death reports
- 1–9 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Nonstandard Device, Computer Software Problem, Use of Incorrect Control/Treatment Settings, Patient Data Problem, Installation-Related Problem, Application Program Problem, Application Program Problem: Parameter Calculation Error 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