MAUDE manufacturer profile
SIEMENS HEALTHINEERS AG · JAK
MAUDE profile for System, X-Ray, Tomography, Computed
Key facts
| Manufacturer | SIEMENS HEALTHINEERS AG |
|---|---|
| Manufacturer group | SIEMENS HEALTHINEERS AG |
| Product code | JAK |
| Product code name | System, X-Ray, Tomography, Computed |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, No Known Impact Or Consequence To Patient, Device Operates Differently Than Expected, Use of Device Problem, Improper or Incorrect Procedure or Method, Human-Device Interface Problem, Adverse Event Without Identified Device or Use Problem, Laceration(s) 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