The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0115-2020·Announced 2019-12-25

GE Healthcare Recalls Aestiva 7900 Anesthesia Systems for Cybersecurity Vulnerability

GE Healthcare is recalling 7,168 Aestiva 7900 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 involves a cybersecurity vulnerability in a medical device that could allow a malicious actor to send fraudulent parameters, representing a risk-of-harm product where injury has not yet been reported, consistent with the 'High' severity criteria.

Plain-English summary

GE Healthcare, LLC is recalling 7,168 Aestiva 7900 anesthesia systems, including specific model numbers such as 1006-9300-000 and 1006-9305-000. The devices were distributed worldwide.

The recall was initiated because certain Aespire and Aestiva anesthesia systems 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.

Hospitals and healthcare facilities with these devices should contact GE Healthcare for further instructions on how to address the vulnerability. No specific illnesses or injuries are reported in the source text, but the potential for compromised device functionality poses a risk to patient safety.

The recalled product

Product
Aestiva 7900, Model Numbers: a) 1006-9300-000 b) 1006-9305-000 c) 1006-9118-000 d) 1006-9112-000 e) 1006-9113-000 f) 1006-9020-000 g) 1006-9033-000 h) 1006-9117-000 i) 1006-9119-000 j) 1006-9030-000 k) 1006-9032-000 l) 1006-9022-000 m) To be provided n)…
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Anesthesia Systems
Hazard
Affected units
7,168

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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