Del Medical, Inc. DM-FMT18MRecalls & reported problems
Del Medical, Inc. · The DM-FMT18M is the version of the DMX system which uses a floor mounted tube stand and does not perform tracking or stitching. This x-ray system can perform a comprehensive range of radiographic procedures. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00858340006189), received between May 29, 2026 and May 29, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unexpected/Unintended Radiation Output” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Unexpected/Unintended Radiation Output1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 29, 2026Unexpected/Unintended Radiation Output
ON (B)(6) 2026, THE PHYSICIST FAILED THE GENERATOR DURING INSTALLATION FOR ALLOWING EXPOSURE WITHOUT THE REQUIREMENT TO RESET A PREVIOUS AEC BACK UP TIME ERROR. THE UNIT WAS USING A CM SERIES GENERATOR INTEGRATED WITH VIVIX DR. THERE WAS NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25339231 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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