The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0117-2020·Announced 2019-12-25

GE Healthcare Recalls Aestiva 7100 Anesthesia Systems Due to Cybersecurity Vulnerability

GE Healthcare is recalling 473 Aestiva 7100 anesthesia systems worldwide due to a cybersecurity vulnerability that could allow malicious actors to send fraudulent flow sensor correction parameters.

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 is classified as FDA Class II and involves a cybersecurity vulnerability in a medical device that could lead to the injection of fraudulent parameters, representing a risk of harm where injury has not yet been reported.

Plain-English summary

GE Healthcare, LLC is recalling 473 Aestiva 7100 anesthesia systems, including various model numbers, due to a cybersecurity vulnerability. The recall is classified as Class II by the U.S. Food and Drug Administration.

The affected devices were noted to have a vulnerability to a cyber-attack when connected to the 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 recall covers devices distributed worldwide. No specific instructions for consumers or healthcare providers are provided in the source text beyond the identification of the affected units.

The recalled product

Product
Aestiva 7100, Model Numbers: 1. 1006-9320-000 2. 1006-9321-000 3. 1006-9320-000-001101 4. 1006-9021-000 5. 1006-9012-000 6. 1006-9111-000 7. 1006-9321-000-007639 8. 1006-9321-000-000023 9. 1006-9321-000-015180 10. 1006-9320-000-010369 11. 1006-9321-000-019486 12.…
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Anesthesia Systems
Hazard
Affected units
473

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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