GE Healthcare Recalls Core Services Hub V8 Due to Data Association Errors
GE Healthcare is recalling Core Services Hub V8 software because historical imaging data may be incorrectly associated with the wrong patient, potentially leading to misdiagnosis.
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: The recall involves a risk-of-harm product (medical device software) where injury or misdiagnosis has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
GE Healthcare is recalling Core Services Hub V8, a set of backend services including Cross Enterprise (XE) and Workflow Core (WFC) services that enable enterprise imaging workflows. The recall covers all versions of the software and affects approximately 250 systems distributed worldwide and across the United States.
The recall is issued because, under certain conditions, historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record. This error could lead to misdiagnosis or a delay in patient care.
Healthcare facilities using the affected systems should contact GE Healthcare for instructions on how to resolve the issue. The source text does not specify a specific action for consumers, as the product is enterprise medical software.
The recalled product
- Product
- Core Services Hub V8, a set of backend services including Cross Enterprise (XE) and Workflow Core (WFC) services that enables enterprise imaging workflows, All versions
- Manufacturer
- GE Healthcare
- Category
- Medical Device — Software
- Affected units
- 250
Distribution
Distributed nationwide across the United States.
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