GE Healthcare Recalls Aestiva MRI Systems Due to Cybersecurity Vulnerability
GE Healthcare is recalling 502 Aestiva MRI systems worldwide due to a cybersecurity vulnerability that could allow malicious actors to send fraudulent flow sensor correction parameters.
What this means for you
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) with a cybersecurity vulnerability that could lead to fraudulent data injection, but the source text does not report any injuries, illnesses, or deaths, fitting the 'High' severity criteria for theoretical or unreported harm.
Plain-English summary
GE Healthcare, LLC is recalling 502 Aestiva MRI systems, including various model numbers such as 1006-9310-000 and 1006-9110-000, distributed worldwide. The recall is due to a cybersecurity vulnerability identified in certain Aespire and Aestiva Anesthesia Systems.
The vulnerability exists when the systems are connected to a hospital network. An insufficiently secured terminal server may provide an opportunity for a malicious actor that has already penetrated the hospital network to send fraudulent flow sensor correction parameters. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Healthcare facilities should contact GE Healthcare for instructions on how to secure the devices or apply necessary patches. Consumers and patients should consult their healthcare providers regarding the status of their equipment and any potential impact on their care.
The recalled product
- Product
- Aestiva MRI, Model Numbers: a) 1006-9310-000 b) 1006-9110-000 c) 1006-9023-000 d) 1006-9028-000 e) 1006-9310-000-305077 f) 1006-9310-000-015243 g) 1006-9310-000-017602 h) 1006-9310-000-103785 I) 1006-9310-000-025109 j) 1006-9310-000-009650 k) 1006-9310-000-015224 l) 1
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — MRI Systems
- Affected units
- 502
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 recalled by GE Healthcare, 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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