Konica Minolta SW (PACS) Exa EXA 01-04-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00817100020193), received between Nov 10, 2020 and Feb 5, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (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 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.

• MalfunctionFeb 5, 2021Failure to Transmit Record; Communication or Transmission Problem; Failure to Transmit Record; Communication or Transmission Problem

  CUSTOMER REPORTED THAT STUDIES ARE BEING RECEIVED BUT NOT MOVING FROM CACHE. CUSTOMER REPORTED POTENTIAL DELAY IN PATIENT CARE, AS THE DATE OF THE STUDY WAS (B)(6) 2021 AND THE STUDY WAS NOT RECEIVED UNTIL (B)(6) 2021.

  Patient problems: Insufficient Information

  MAUDE report 11288950 ↗
• MalfunctionNov 10, 2020No Display/Image; Display or Visual Feedback Problem; Output Problem; No Display/Image; Display or Visual Feedback Problem; Output Problem

  CUSTOMER REPORTED FRAME SKIPPING ISSUES WHEN PLAYING CINE SERIES. THE RADIOLOGIST RECENTLY MISSED A BRAIN BLEED ON A PATIENT WHICH CAUSED A NEGATIVE OUTCOME, BUT DID NOT RESULT IN DEATH. THE BRAIN BLEED APPARENTLY SHOWED ON ONLY ONE IMAGE AND IT WAS THE IMAGE THAT WAS SKIPPED. INFORMATION REPORTED INDICATES A REPORTABLE MALFUNCTION DATA DISPLAY ISSUE (NON-IMAGE QUALITY), WHICH MAY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY REQUIRING MEDICAL INTERVENTION; THEREFORE, A REPORTABLE MALFUNCTION WILL BE FILED.

  Patient problems: Brain Injury

  MAUDE report 10820482 ↗