Recall Z-0551-2024 ยท LLZ System, Image Processing, Radiological
CHANGE HEALTHCARE CANADA COMPANY
Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.
| Date | Dec 14, 2023 (initiated Nov 1, 2023) |
| Status | Open, Classified |
| Reason | Under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share systems has been incorrectly associated with another patient's study. |
| Root cause | Software design |
| Action | The recalling firm issued an Urgent Field Safety Notice dated 11/1/2023 which explained the issue that under certain circumstances, one or more of the following three issues may occur: (1) Existing radiology reports may be associated with the wrong patient or study; (2) radiology reports may be missing from imaging studies; and (3) patient metadata in DICOM images may be overwritten with metadata from another patient or study. The notice reports the issue has only existed in the field since it's implementation on 10/26/2023 and the recalling firm is in the process of identifying a list of im |
| Quantity | 454 |
| Distribution | US Nationwide distribution. There was no military/government distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K203249 | Nucleus.io Nucleushealth, LLC, Dec 4, 2020 |