Z-0551-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 20, 2023
- Initiation Date
- November 1, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 454
Product Description
Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.
Reason for Recall
Under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share systems has been incorrectly associated with another patient's study.
Distribution Pattern
US Nationwide distribution. There was no military/government distribution.
Code Information
Version 1.4, UDI (01)17540262160093(10)010400