FDAFDA · Food and drugs·Recall number Z-0551-2024
Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.
Published December 20, 2023 · Recall initiated: November 1, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share systems has been incorrectly associated with another patient's study.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- CHANGE HEALTHCARE CANADA COMPANY
- Distributor
- US Nationwide distribution. There was no military/government distribution.
- Lot
- Version 1.4, UDI (01)17540262160093(10)010400
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Canada
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