DeVilbiss DV6X-619Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885304020585), received between Apr 17, 2025 and Apr 17, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Misassembled” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K071397); they may or may not involve this specific model.

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 16, 2026.

Recalls naming this device

1. Apr 11, 2025Open, Classified

   Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing.

   Z-1727-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2025Component Misassembled; Component Misassembled

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A REPORT OF A DC CAR CHARGER BY THE PROVIDER, WHO STATED THAT THE CHARGER TIP BURNED THE END USER'S HAND DURING USE. THE END USER PLACED ICE ON THE CONTACT SPOT. THERE WAS NO SERIOUS INJURY THAT REQUIRED MEDICAL ATTENTION. ALTHOUGH THE END USER SUSTAINED A BURN RELATED TO THE USE OF THE DEVICE, THE INFORMATION PROVIDED INDICATES NO MEDICAL INTERVENTION WAS REQUIRED AND THUS NOT A REPORTABLE SERIOUS INJURY. THIS DEVICE IS BEING RECALLED. THE RES RECALL NUMBER HAS YET TO BE ISSUED. THE ROOT CAUSE IS THAT THE SUPPLIER OF THE CHARGER SWITCHED THE LOCATION OF THE FUSE AND THE SPRING DURING ASSEMBLY. THERE HAVE BEEN NO COMPLAINTS OF SERIOUS INJURY TO DATE ASSOCIATED WITH THIS ISSUE. THERE HAS BEEN ONE OTHER SUBJECTIVE COMPLAINT OF MINOR THERMAL INJURY TO FINGERS/HAND REPORTED TO DATE, WHICH RESULTED IN MINOR TRANSIENT PAIN, AND NO NEED FOR MEDICAL INTERVENTION. THESE TWO COMPLAINTS REPRESENT (B)(4) OF THE AT RISK POPULATION OF DEVICES.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 21854445 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071397. One submission often covers many models, so check the product and lot details in each record.

• Z-1558-2023 · Mar 9, 2023 · Open, Classified
  DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR
• Z-0724-2023 · Nov 18, 2022 · Open, Classified
  DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q