D-EVO II C35 DR-ID 1211 SE A ERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04547410309294), received between Mar 2, 2023 and Mar 2, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON FEBRUARY 15, 2023, FUJIFILM CORPORATION BECAME AWARE OF AN EVENT INVOLVING FDR D-EVO II PANEL. IT WAS REPORTED THAT A TECHNICIAN TRIPPED OVER THE POWER CABLE AND FELL, TEARING THE ULNAR COLLATERAL LIGAMENT IN HER RIGHT THUMB. THE TECHNICIAN WAS TRIAGED IN THE EMERGENCY ROOM FOLLOWING THE INCIDENT AND WAS INFORMED THAT SURGERY WILL BE REQUIRED TO REPAIR THE TEAR. THE TECHNICIAN WAS RELEASED FROM THE EMERGENCY ROOM IN STABLE CONDITION. THERE IS NO DEATH REPORTED WITH THE EVENT.

  Patient problems: Damage to Ligament(s)

  MAUDE report 16466370 ↗
• InjuryMar 2, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(6) 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION BECAME AWARE OF AN EVENT INVOLVING FDR D-EVO II PANEL. IT WAS REPORTED THAT A TECHNICIAN TRIPPED OVER THE POWER CABLE AND FELL, TEARING THE ULNAR COLLATERAL LIGAMENT IN HER RIGHT THUMB. THE TECHNICIAN WAS TRIAGED IN THE EMERGENCY ROOM FOLLOWING THE INCIDENT AND WAS INFORMED THAT SURGERY WILL BE REQUIRED TO REPAIR THE TEAR. THE TECHNICIAN WAS RELEASED FROM THE EMERGENCY ROOM IN STABLE CONDITION. THERE IS NO DEATH REPORTED WITH THE EVENT.

  Patient problems: Damage to Ligament(s)

  MAUDE report 16466333 ↗