Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Flow sensors that may be installed in the following GEHC Recalled by GE Healthcare, LLC Due to The flow sensors built prior to June 2021...

Date: August 2, 2021
Company: GE Healthcare, LLC
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact GE Healthcare, LLC directly.

Affected Products

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; (6) Aespire View; (7) Avance; (8) Avance CS2, GTIN 00840682102292; (9) Aisys; (10) Aisys CS2, GTIN 00840682102322; (11) Amingo; (12) 9100 NXT Config, Aelite NXT; (13) Protiva 7100;

Quantity: Estimated 310,072 flow sensors

Why Was This Recalled?

The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts that could cause leaks resulting in incorrect anesthesia machine tidal volumes potentially leading to over-delivery of volume to the patient.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About GE Healthcare, LLC

GE Healthcare, LLC has 474 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report