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U.S. Department of Health and Human Services

Class 2 Device Recall Change Healthcare Stratus

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  Class 2 Device Recall Change Healthcare Stratus see related information
Date Initiated by Firm November 01, 2023
Date Posted December 14, 2023
Recall Status1 Open3, Classified
Recall Number Z-0551-2024
Recall Event ID 93451
510(K)Number K203249  
Product Classification System, image processing, radiological - Product Code LLZ
Product Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.
Code Information Version 1.4, UDI (01)17540262160093(10)010400
Recalling Firm/
Manufacturer		 CHANGE HEALTHCARE CANADA COMPANY
10711 Cambie Rd Suite 130
Richmond Canada
For Additional Information Contact Mr. Jay Sloman
404-338-2542
Manufacturer 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.
FDA Determined
Cause 2		 Software design
Action The recalling firm issued an Urgent Field Safety Notice dated 11/1/2023 which explained the issue that under certain circumstances, one or more of the following three issues may occur: (1) Existing radiology reports may be associated with the wrong patient or study; (2) radiology reports may be missing from imaging studies; and (3) patient metadata in DICOM images may be overwritten with metadata from another patient or study. The notice reports the issue has only existed in the field since it's implementation on 10/26/2023 and the recalling firm is in the process of identifying a list of impacted patient records and the consignee will be provided an update within 24 hours. The circumstances under which the issue occurs are still being investigated. Risk to patient is provided along with the immediate actions to be taken to reduce the risk to patient. The actions include if a radiology report is expected and not available in systems downstream from Imaging Share, customers are advised to contact the radiology department where the reporting originally occurred. Customers are advised to review the audit log for instances of "Exam info modified" to determine if changes to study details have been made in error. In situations where patient demographics have been changed, this audit log will provide the original values for impacted patient records. As this issue extends beyond Radiology department workflows, customers are advised to have heightened awareness to correlate metadata with other systems to ensure accuracy of records. As Imaging Share can distribute images and reports to downstream systems, customers are also advised to review any potentially impacted patient records as identified in the audit log in all downstream systems and workflows. The notice informs the customer that the recalling firm has implemented a fix to prevent further impact to patient records in version 1.4.0 hotfix 02. Regarding recommended actions for the customer to take on potent
Quantity in Commerce 454
Distribution US Nationwide distribution. There was no military/government distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = NucleusHealth, LLC
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