Device product
Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.
Z-0551-2024
Product summary
- Event
- Event 93451
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 454
- Official record key
device-enforcement:Z-0551-2024
Official wording
Reason: Under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share systems has been incorrectly associated with another patient's study.
Code information: Version 1.4, UDI (01)17540262160093(10)010400
Distribution pattern: US Nationwide distribution. There was no military/government distribution.
Derived failure modes
-
Unknown
Under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share systems has been incorrectly associated with another patient's study.