FDA Medical Device Recalls (openFDA)
CHANGE HEALTHCARE CANADA COMPANY: Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.
- Recall number
- Z-0551-2024
- Recalling firm
- CHANGE HEALTHCARE CANADA COMPANY
- Product
- Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.
- Status
- Open, Classified
- Initiated
- 2023-11-01
- Posted
- 2023-12-14
- Terminated
- not on file
- Reason
- Under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share systems has been incorrectly associated with another patient's study.
- Root cause
- 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
- 454
- Distribution
- US Nationwide distribution. There was no military/government distribution.
- Lot, serial or model codes
- Version 1.4, UDI (01)17540262160093(10)010400
- 510(k) numbers
- ["K203249"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 3003757840
- Firm city
- Richmond
- Firm state
- not on file
- Firm country
- Canada
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28