Product Safety Recalls

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CHANGE HEALTHCARE CANADA COMPANY Recall 93451

Page Last Updated: May 20, 2024

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

CHANGE HEALTHCARE CANADA COMPANY Recall 93451 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0551-2024
Event ID93451
Event DescriptionChange Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.
Product TypeDevices
DistributionUS Nationwide distribution. There was no military/government distribution.
Quantity454
Recall ReasonUnder certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share systems has been incorrectly associated with another patient's study.
Device Classification20231220
Device Code InfoVersion 1.4, UDI (01)17540262160093(10)010400
Center Classification Date20231214
Recall Initiation Date20231101
Recalling FirmCHANGE HEALTHCARE CANADA COMPANY
Initial Notification Letter
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