FDA-Device2023-12-20Class II
Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.
CHANGE HEALTHCARE CANADA COMPANY
Hazard
Under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share systems has been incorrectly associated with another patient's study.
Sold states
US Nationwide distribution. There was no military/government distribution.
Affected count
454
Manufactured in
10711 Cambie Rd Suite 130, N/A, Richmond, N/A, Canada
Products
Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0551-2024Don't want to check this manually?
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