MAUDE report

MAUDE report 14434: SUPERFICIAL X-RAY UNIT

No Answer Provided · received Jun 30, 1994 · PHILIPS MEDICAL SYSTEMS

Key facts

MDR report key 14434
Report number MW1002674
Event type No Answer Provided
Brand name SUPERFICIAL X-RAY UNIT
Model number RT-100
Manufacturer PHILIPS MEDICAL SYSTEMS
Product code IZO
Device class Class I
PMA or 510(k) number Device Exempt
Date received by FDA Jun 30, 1994
Report date Jun 13, 1994
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
  • None Injury reports for this brand
  • No 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