The Recall Desk
HighFDA (Devices)·Z-0116-2020·Announced 2019-12-25

GE Healthcare Recalls Aespire and Aestiva Anesthesia Systems for Cybersecurity Vulnerability

GE Healthcare is recalling Aespire and Aestiva anesthesia systems 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 (anesthesia system) where a cybersecurity vulnerability could lead to device malfunction, but no injuries or illnesses have been reported in the source text.

Plain-English summary

GE Healthcare, LLC is recalling certain Aespire and Aestiva Anesthesia Systems. The recall involves 19,351 devices distributed worldwide. The affected devices include specific model numbers and serial numbers listed in the official recall documentation.

The recall is due to a vulnerability to cyber-attacks 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.

Hospitals and healthcare facilities should check their inventory for the affected model and serial numbers. Users should contact GE Healthcare for instructions on how to secure the devices or obtain replacements.

The recalled product

Product
Aespire 7100, Model Numbers: 1. 1009-9000-000-009469 2. 1009-9000-000 3. 1009-9000-000-013913 4. 1009-9000-000-001366 5. 1009-9000-000-009857 6. 1009-9003-000 7. 1009-9000-000-008120 8. 1009-9000-000-009600 9. 1009-9000-000-014290 10. 1009-9000-000-010585 11. 1009-90
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Anesthesia Systems
Hazard
Affected units
19,351

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)

  • Model

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.

See all 4 products in this recall →

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Same hazard · cybersecurity vulnerability

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