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Change Healthcare Stratus Imaging PACS 1.4 and Stratus… recallZ-0551-2024 · Change Healthcare Canada Company · initiated Nov 1, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Change Healthcare Canada Company or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share systems has been incorrectly associated with another patient's study.

FDA root cause category: Software design

What the company is doing

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

Recall details

Recall number
Z-0551-2024
Status
Open, Classified
Initiated by the company
Nov 1, 2023
Posted by the FDA
Dec 14, 2023
Recalling firm
Change Healthcare Canada Company
Quantity
454
Product code
LLZ
FDA submissions
K203249
Distribution
US Nationwide distribution. There was no military/government distribution.

Product description

Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.

Code information (models, lots, serial numbers)

Version 1.4, UDI (01)17540262160093(10)010400

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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