OEC 20767 (UDI 01618125152208)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 01618125152208), received between Jul 22, 2024 and Jul 22, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination” (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. How this data works · Data updated Oct 13, 2026.

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.

• MalfunctionJul 22, 2024Contamination; Contamination

  IT WAS REPORTED BY A DISTRIBUTOR IN JAPAN: WHILE THEY WERE OPERATING, THEY OPENED A PACKAGE AND TRIED TO PUT THE PRODUCT ON THE C-ARM, SOMETHING DROPPED. IT WAS A PART SIMILAR TO ONE OF THE PRODUCT PARTS. THEY INITIALLY THOUGHT IT WAS THE PART CAME OFF THE PRODUCT THEY REMOVED FROM THE PACKAGE AND CHECKED THE PRODUCT IMMEDIATELY. HOWEVER, THEY FOUND THAT NOTHING WAS MISSING FROM THE PRODUCT. THE PRODUCT WAS IN PERFECT CONDITION. THEY THINK AN EXTRA PART GOT INTO THE PACKAGE WITH THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19796647 ↗