DRX Plus 3543C DetectorRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 60889974000238), received between Aug 11, 2021 and Aug 11, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Image Display Error/Artifact” (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 16, 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.

• InjuryAug 11, 2021Image Display Error/Artifact; Image Display Error/Artifact

  ON (B)(6) 2021, CARESTREAM HEALTH (CSH) WAS INFORMED OF AN INCIDENT RELATED TO THE DRX PLUS 3543C DETECTOR WHICH OCCURRED AT (B)(6) HOSPITAL ((B)(6)). PER THE REPORT, AFTER A SURGICAL PROCEDURE WAS COMPLETED AND THE PATIENT WAS STITCHED UP, PER HOSPITAL PROTOCOL, THE CUSTOMER PERFORMED A COUNT OF SURGICAL INSTRUMENTS AND DETERMINED THE COUNT TO BE OFF. THE CUSTOMER THEN PROCEEDED AS FOLLOWS: TOOK 1ST IMAGE OF ONE (1) FORCEPS USING A DRX REVOLUTION SYSTEM AND THE DRX PLUS 3543C DETECTOR (SN: (B)(4)). TOOK 2ND AND 3RD IMAGES OF PATIENT ABDOMEN WHICH SHOWED A FAINT SIGNAL, RETAINED FROM THE INITIAL FORCEPS IMAGE, WHICH THE CUSTOMER BELIEVED TO BE THE MISSING INSTRUMENT. AS A RESULT, THE PATIENT WAS RE-OPENED IN ERROR AS THE FORCEPS WERE NOT LEFT IN THE PATIENT. THERE WAS NO INJURY OR ADVERSE EFFECT TO THE PATIENT DUE TO THIS INCIDENT. HOWEVER, DUE TO THE CUSTOMER ERROR IN VIEWING THE IMAGES, THE PATIENT WAS RE-OPENED AFTER BEING STITCHED UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12310935 ↗