Medical imaging servers recalled over security vulnerability affecting patient data
GE is recalling 7,302 AW Server systems after identifying a security vulnerability that, if exploited, could compromise the confidentiality, integrity and availability of patient data.
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: Scored 3 under the risk-of-harm criterion: a vulnerability that could compromise the integrity of patient data creates a clinical risk, and no exploitation or injury is reported.
Plain-English summary
AW Server 2.0, AW Server 3.0, AW Server 3.1 and AW Server 3.2 are being recalled. The firm has identified a security vulnerability in the AW Server products.
If the vulnerability were exploited, a malicious actor could compromise the confidentiality, integrity and availability of patient data.
The recall covers 7,302 units, of which 1,381 are in the United States and 5,921 outside it, carrying UDI-DI 00840682102384. Distribution was nationwide in the United States and worldwide internationally. The FDA has classified the action as Class II.
Sites running affected system IDs should follow GE's instructions for remediation.
The recalled product
- Product
- AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2
- Manufacturer
- GE Medical Systems, SCS
Distribution
Distributed nationwide across the United States.
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