Medical imaging software incorrectly displays patient studies to wrong patients
Change Healthcare's Stratus Imaging PACS software can incorrectly associate patient imaging studies with the wrong patients. Approximately 454 affected units have been distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall with no reported patient illnesses or injuries. The hazard represents a risk-of-harm through potential misdiagnosis or wrong-patient treatment due to patient data misassociation, but no such incidents are documented. Per the FDA rubric, high-risk medical device flaws without reported injury qualify as High severity.
Plain-English summary
Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4 are medical imaging software systems used by healthcare facilities. The systems process HL7 messages—a standard format for medical data communication—to manage and retrieve patient imaging studies.
Under certain circumstances, information from HL7 messages received by these systems has been incorrectly associated with another patient's study. This data integrity issue means a patient's imaging study could be linked with another patient's medical record instead of their own.
Approximately 454 units of the affected software versions have been distributed nationwide. Healthcare facilities using this software should be aware of this potential data association error and take appropriate measures to ensure patient records are correctly matched with imaging studies.
The recalled product
- Product
- Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.
- Manufacturer
- CHANGE HEALTHCARE CANADA COMPANY
- Affected units
- 454
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Version 1.4
- UDI (01)17540262160093(10)010400
Distribution
Distributed nationwide across the United States.
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