FDA Enforcement
Class II
Ongoing
Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.
Recall: Z-0551-2024
·
Reported December 20, 2023
Enforcement
- Recall Number
- Z-0551-2024
- Event ID
- 93451
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- CHANGE HEALTHCARE CANADA COMPANY
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 20, 2023
- Initiation Date
- November 1, 2023
- Classification Date
- December 14, 2023
- Address
- 10711 Cambie Rd Suite 130, N/A, Richmond, N/A, N/A, Canada
Description
Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.
Reason
Under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share systems has been incorrectly associated with another patient's study.
Code Info
Version 1.4, UDI (01)17540262160093(10)010400
Distribution
US Nationwide distribution. There was no military/government distribution.
Quantity
454