MAUDE report

MAUDE report 21835: STEPPING GANTRY

Injury · received Apr 20, 1995 · SIEMENS MEDICAL SYSTEMS, INC.

Key facts

MDR report key 21835
Report number 21835
Event type Injury
Brand name STEPPING GANTRY
Model number 9359142G127E
Manufacturer SIEMENS MEDICAL SYSTEMS, INC.
Product code IYX
Device class Class I
PMA or 510(k) number Device Exempt
Date received by FDA Apr 20, 1995
Report date Mar 16, 1995
Report source Maude

At a glance

  • None Device problems coded
  • 100–999 MAUDE reports for this product code
  • 1–9 MAUDE reports for this brand
  • None Death reports for this brand
  • 1–9 Injury reports for this brand
  • Yes Adverse event flagged
  • Yes Product problem flagged

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About MAUDE medical device reports

MAUDE holds medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions submitted to the FDA by manufacturers, importers, user facilities and the public. A report alone does not establish that a device caused an event.

Source: U.S. Food and Drug Administration (FDA), MAUDE (Manufacturer and User Facility Device Experience) database · Source date:

Browse all MAUDE medical device reports