medical Class II Updated 2023-12-20

CHANGE HEALTHCARE CANADA COMPANY recalls Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imagi

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Version 1.4, UDI (01)17540262160093(10)010400
View official government recall

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