Faxitron CoreVision 5x10Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00857069006005), received between Jul 30, 2021 and Aug 19, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (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

Recent adverse event reports

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

• MalfunctionAug 19, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON JULY 14TH DURING AN IMAGING PROCEDURE FOR A SAMPLE, THE SPECIMEN FELL OFF THE DRAWER AND INTO THE MACHINE. THE STAFF WEREN´T ABLE TO RETRIEVE THE SAMPLE AND THE PATIENT HAD TO BE RESCHEDULED FOR A NEW TISSUE ACQUISITIONS PROCEDURE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12345520 ↗
• MalfunctionJul 30, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON JULY 14TH DURING AN IMAGING PROCEDURE FOR A SAMPLE, THE SPECIMEN FELL OFF THE DRAWER AND INTO THE MACHINE. THE STAFF WEREN´T ABLE TO RETRIEVE THE SAMPLE AND THE PATIENT HAD TO BE RESCHEDULED FOR A NEW TISSUE ACQUISITIONS PROCEDURE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12256550 ↗