GXDP-300Recalls & reported problems
PaloDEx Group Oy · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 06430035872435), received between Jun 2, 2017 and Jun 2, 2017 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Alarm System” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device Alarm System2
Patient problems
- Tinnitus2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 2, 2017Device Alarm System; Device Alarm System
IT WAS REPORTED THAT THE VOLUME OF EXPOSURE WARNING SPEAKER OF A DIGITAL PANORAMIC X-RAY UNIT GXDP-300 (SERIAL # (B)(4)) IS TOO LOUD, AND HAS ALLEGEDLY CONTRIBUTED TO AN OPERATOR'S CLAIM OF PERMANENT RINGING IN EARS.
Patient problems: Tinnitus
MAUDE report 6607953 ↗InjuryJun 2, 2017Device Alarm System; Device Alarm System
IT WAS REPORTED THAT THE VOLUME OF EXPOSURE WARNING SPEAKER OF A DIGITAL PANORAMIC X-RAY UNIT GXDP-300 (SERIAL # (B)(4)) IS TOO LOUD, AND HAS ALLEGEDLY CONTRIBUTED TO AN OPERATOR'S CLAIM OF PERMANENT RINGING IN EARS.
Patient problems: Tinnitus
MAUDE report 6607945 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.