GE Healthcare Enterprise Archive V8 Software Recalled for Data Association Errors
GE Healthcare is recalling Enterprise Archive V8 software because historical imaging data may be incorrectly associated with different patients, 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 software) where injury or misdiagnosis has not yet been reported, fitting the 'High' severity criteria for theoretical harm without confirmed incidents.
Plain-English summary
GE Healthcare is recalling Enterprise Archive V8, a software product used for receiving, archiving, and sending electronic medical data. The recall covers all versions of the software and affects 1,298 systems distributed worldwide and nationwide in the US.
The recall is due to a defect where, 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 this software should contact GE Healthcare for instructions on how to resolve the issue. No specific instructions for end consumers are provided as this is a medical device software product used by healthcare professionals.
The recalled product
- Product
- Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versions
- Manufacturer
- GE Healthcare
- Category
- Medical Device — Software
- Affected units
- 1,298
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 (1)
- UDI-DI: V4 - 00195278409287
Distribution
Distributed nationwide across the United States.
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