Change Healthcare Stratus Imaging PACS 1.4.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 17540262160093), received between Nov 22, 2023 and Nov 22, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Application Program Problem” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Nov 1, 2023Class IIOpen, Classified

   Under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share systems has been incorrectly associated with another patient's study.

   Z-0551-2024 · Root cause: Software design · Recall details · FDA record ↗

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.

• MalfunctionNov 22, 2023Computer Software Problem; Application Program Problem; Data Problem; Patient Data Problem; Computer Software Problem; Application Program Problem; Data Problem; Patient Data Problem

  UNDER CERTAIN CIRCUMSTANCES, INFORMATION FROM HL7 MESSAGES RECEIVED BY THE STRATUS PACS/ IMAGING SHARE SYSTEM HAVE BEEN INCORRECTLY ASSOCIATED WITH ANOTHER PATIENT'S STUDY WHICH MAY RESULT IN THE FOLLOWING POTENTIAL SCENARIOS: 1. A SUBSET OF PATIENT STUDY METADATA (PATIENT NAME, MRN, ACCESSION NUMBER, DOB, GENDER, STUDY PROCEDURE) HAS BEEN UPDATED WITH ANOTHER PATIENT'S METADATA (PATIENT NAME, MRN, ACCESSION NUMBER, DOB, GENDER, STUDY PROCEDURE). THIS MAY RESULT IN PATIENT'S IMAGES BEING LABELED INCORRECTLY WITH ANOTHER PATIENT'S METADATA AND ASSOCIATED WITH THE WRONG PATIENT RECORD. 2. AS A RESULT OF INCORRECT IMAGE DEMOGRAPHICS, THE MISLABELED IMAGES MAY NOT BE ASSOCIATED WITH THE RECORD FOR THE PATIENT THAT HAD AN IMAGING STUDY. 3. AN ISSUED REPORT ON A STUDY THAT IS SENT TO THE STRATUS IMAGING SYSTEM VIA HL7, MAY GET ATTACHED TO ANOTHER PATIENT'S STUDY. THIS MAY RESULT IN A REPORT BEING ASSOCIATED WITH THE INCORRECT PATIENT STUDY. 4. AS A RESULT OF INCORRECT REPORT ASSOCIATION DESCRIBED ABOVE, SOME PATIENTS WILL HAVE MISSING REPORTS WITH NO REPORT BEING DISPLAYED IN THE STUDY. THE INCORRECT ASSOCIATION OF IMAGE AND REPORT METADATA ACROSS IMAGING STUDIES CAN OCCUR WITHIN YOUR FA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18193816 ↗