CHANGE HEALTHCARE CANADA COMPANY recalls Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.

Recalled December 20, 2023 · FDA recall Z-0551-2024 · CHANGE HEALTHCARE CANADA

Hazard

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

Units

454

Sold at

US Nationwide distribution. There was no military/government distribution.

Description

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

Product

Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.

Manufacturer(s)

CHANGE HEALTHCARE CANADA COMPANY

Made in

Canada

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →