The Recall Desk
HighFDA (Devices)·Z-2595-2021·Announced 2021-10-06

Anesthesia Flow Sensors Recalled for Tube Damage and Potential Gas Leaks

GE Healthcare is recalling approximately 310,000 replacement flow sensors for anesthesia machines manufactured before June 2021. The sensors may have damaged tubes that leak, causing incorrect anesthesia delivery to patients.

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: This is a Class II recall of a medical device that presents a risk of harm (over-delivery of anesthesia) but no illnesses or injuries have been reported in the source text. Under the rubric, a risk-of-harm product where no injuries have been reported falls into the High category.

Plain-English summary

GE Healthcare is recalling approximately 310,072 replacement flow sensors used in anesthesia machines. The recalled sensors are spare parts with multiple part numbers including 2089610-001, 2089610-001-S, 2087640-001, 2087640-001-S, 2096513-001-S, 5697309, and 5697310. The affected sensors were manufactured prior to June 2021, which can be identified by the date etched on the sensor body.

The recalled sensors may have small punctures or cuts in the tubes, which could cause gas leaks. These leaks could result in incorrect tidal volumes being delivered by the anesthesia machine, potentially leading to over-delivery of anesthesia to patients.

The sensors were distributed nationwide in the United States, including Puerto Rico, as well as internationally to over 100 countries across multiple continents.

The recalled product

Product
Flow sensors kept as stand-alone user replaceable spare parts for the GEHC anethesia machines: 2089610-001 FLOW SENSOR, LEGACY VAR ORF BCG (blue, cleanable) 2089610-001-S FLOW SENSOR, LEGACY VAR ORF BCG, SERVICE (blue, cleanable) 2087640-001 FLOW SENSOR, LEGACY VAR ORF AUTOC
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 →

Related recalls

Same manufacturer · GE Healthcare, LLC

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Same hazard · tube damage

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