Revolution CT ES X-ray Computed Tomography System Security Vulnerability Recall
GE Medical Systems is recalling Revolution CT ES and related CT systems due to a potential security vulnerability in the AW Server deployed via Edison Health Link based CT Smart Subscription. The vulnerability may affect system security.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a cybersecurity vulnerability in medical device software with no reported injuries or unauthorized access documented in the source text. The hazard is theoretical rather than confirmed active exploitation, making it a precautionary recall.
Plain-English summary
GE Medical Systems, LLC is recalling the Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15, along with certain Revolution Apex and Revolution Ascend systems. The recall addresses a potential security vulnerability in the AW Server that is deployed via Edison Health Link (EHL) based CT Smart Subscription when used in conjunction with these affected CT systems.
Approximately 10 units with the following serial numbers have been distributed nationwide and worldwide: REVV82200058CN, REVV82200046CN, REVV82100016CN, REVV82200014CN, REVV82100027CN, REVV82200047CN, REVV82100031CN, REVV82400010CN, REVV82200017CN, and REVV82400005CN. The UDI-DI is 00840682123471.
Customers who have received these affected systems should contact GE Medical Systems, LLC for guidance on remediation measures to address the security vulnerability.
The recalled product
- Product
- Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15
- Manufacturer
- GE Medical Systems, LLC
- Category
- Medical Device — CT Scanner
- Affected units
- 10
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: 00840682123471
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by GE Medical Systems, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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