Recall Z-0551-2024— CHANGE HEALTHCARE CANADA COMPANY
Class II · Ongoing
Class II FDA medical device recall by CHANGE HEALTHCARE CANADA COMPANY, initiated 2023-11-01. It names one FDA 510(k) clearance: K203249. Product: 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..
- Recalling firm
- CHANGE HEALTHCARE CANADA COMPANY
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-11-01
- Firm location
- Richmond, N/A, Canada
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.