The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2596-2021·Announced 2021-10-06

GE Healthcare anesthesia machine flow sensors may over-deliver anesthetic

Flow sensors in GE Healthcare anesthesia machines built before June 2021 may have damaged tubing that leaks, potentially causing over-delivery of anesthetic to patients.

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: This is a Class II medical device recall with no reports of hospitalization or injury. The hazard—potential over-delivery of anesthesia—poses a real risk of patient harm but is theoretical (not yet documented in practice), meeting the criterion for Score 3: 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

GE Healthcare, LLC has issued a Class II recall of flow sensors used in certain anesthesia machine models, including Aestiva, Aespire, Aisys, Avance, Amingo, Protiva, and Aelite systems. Approximately 310,072 affected flow sensors were manufactured before June 2021.

These flow sensors may contain small punctures or cuts in their internal tubing. Defects in the tubing can cause leaks, resulting in inaccurate measurement of anesthetic tidal volumes and potentially leading to over-delivery of anesthetic to patients during surgery.

The affected flow sensors were distributed nationwide throughout the United States and Puerto Rico. International distribution occurred in over 80 countries. Healthcare facilities worldwide using the affected GE Healthcare anesthesia machine models may have impacted equipment.

No illnesses or injuries related to the defect have been reported to date. This is a Class II recall, indicating potential for adverse health consequences but without reports of serious injury.

The recalled product

Product
Flow sensors that may be installed in the following GEHC anesthesia machines: (1) Aestiva MRI, GTIN 0080682102339; (2) Aestiva 7900; (3) Aestiva 7100; (4) Aespire System Carestation, S/5 Protiva Config., Aespire 100 Compact Wall Mount (Aespire 7100); (5) S/5 Aespire 7900…
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Anesthesia Equipment
Hazard
Affected units
310,072

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

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