| TGA Action ID |
RC-2026-RN-00711-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Centricity Enterprise Archive, Enterprise Archive, Centricity PACS, and Centricity PACS Server
All versions |
| ARTG Number |
162031, 489545 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Under certain conditions, historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care.
This problem may occur in certain historical data migration scenarios, including duplicate accession numbers, duplicate Study Instance UIDs, orderless migration scenarios, and customised data migration use conditions.
There have been no injuries reported to GE HealthCare as a result of this problem. |
| Instructions for Customers/Users |
Pending corrections from GE HealthCare, users can continue to use their systems by following the instructions below
1. Do not perform any new inbound data (DICOM) migration projects. Contact GE HealthCare before starting any new migration projects
2. If using Enterprise Archive with Core Services Hub/Workflow Core Services, when reviewing or exporting prior imaging studies after migration to Enterprise Archive, verify that the study and images within the study are associated with the correct patient as follows:
· Confirm the patient's name, date of birth, and other patient identifiers (e.g, Patient Identification Number/Medical Record Number) only if permanently embedded in the image. Do not rely on patient information in image overlays that can be toggled on and off
· After patient identity has been verified, anatomy, implants, or similar features may be used as a secondary check for inconsistencies that may indicate a possible image mismatch
· Confirm that the acquisition date/time is consistent with the expected study timing
· If patient identity cannot be reliably confirmed using the identifiers and checks described above, treat the affected study or image(s) as patient identity unverified. Do not use the affected content for image/study interpretation or reporting. Follow local procedures for potential patient misidentification (e.g notify PACS administrator, imaging informatics team, radiology management)
GE will contact customers to arrange the correction. |
| Action Commencement Date |
28/09/2026 |
| Responsible Entity |
|
| Contact Information |
1800 659 465 - GE Healthcare Service |