Aespire, Avance, and Aisys Anesthesia Machines Recalled for Connection Risk

Agency Publication Date: October 18, 2024

Summary

Datex-Ohmeda, Inc. (GE HealthCare) is recalling 85,726 Aespire, Avance, and Aisys anesthesia machines because the patient breathing circuit could be accidentally connected to the Auxiliary Common Gas Outlet (ACGO) port. This recall includes several models such as the Aespire 100, 7100, 7900, View, Avance CS2, and Aisys CS2, as well as separate conversion kits. No injuries have been reported, but incorrectly connecting the circuit could prevent a patient from receiving intended ventilation or anesthesia gas.

Risk

If the breathing circuit is mistakenly connected to the wrong port, the patient may not receive necessary oxygen or anesthesia, potentially leading to respiratory distress, lack of oxygen, or other serious health complications.

What You Should Do

This recall affects Aespire, Avance, and Aisys anesthesia machines, along with conversion kits sold under names like CONV KIT SCGO TO ACGO and ACGO ASSY FIELD INSTL.
Check your device for model numbers Aespire 100, 7100, 7900, View, Avance, Amingo, Avance CS2, Aisys, or Aisys CS2. See the Affected Products section below for the full list of affected codes.
Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
Contact GE HealthCare or your authorized medical device distributor for further instructions regarding device configuration and connection verification.
Call the FDA: 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional information.

Your Remedy Options

Other Action

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva

Model / REF:

1009-9000-000

1009-9101-000

1009-9004-000

Serial Numbers:

All Serial Numbers

GTIN:

00840682102261

All devices of the indicated products configured with the AGCO option are potentially affected.

Product: Aespire 100

GTIN:

00840682102261

Product: Aespire 7900

Model / REF:

1009-9012-000

Serial Numbers:

All Serial Numbers

GTIN:

00840682102261

All devices configured with the AGCO option are potentially affected.

Product: Aespire View

Model / REF:

1009-9212-000

Serial Numbers (1527):

1009-9212-000-117639

1009-9212-000-136105

1009-9212-000-518222

1009-9212-000-521025

1009-9212-000-552778

1009-9212-000-090755

1009-9212-000-059245

1009-9212-000-110073

1009-9212-000-203581

1009-9212-000-423283

1009-9212-000-419502

1009-9212-000-427555

1009-9212-000-460867

1009-9212-000-478499

1009-9212-000-109510

1009-9212-000-521303

1009-9212-000-097620

1009-9212-000-102602

1009-9212-000-520908

1009-9212-000-098765

1009-9212-000-076846

1009-9212-000-070149

1009-9212-000-189720

1009-9212-000-140832

1009-9212-000-036279

1009-9212-000-484467

1009-9212-000-520055

1009-9212-000-516124

1009-9212-000-182799

1009-9212-000-161253

1009-9212-000-121684

1009-9212-000-117998

1009-9212-000-499121

1009-9212-000-405786

1009-9212-000-425988

1009-9212-000-309943

1009-9212-000-045250

1009-9212-000-121264

1009-9212-000-478484

1009-9212-000-184939

1009-9212-000-513915

1009-9212-000-049292

1009-9212-000-467900

1009-9212-000-521309

1009-9212-000-243610

1009-9212-000-431587

1009-9212-000-089004

1009-9212-000-248292

1009-9212-000-308148

1009-9212-000-115588

GTIN:

00840682102285

All Serial Numbers for indicated model numbers are affected if configured with the AGCO option.

Product: Avance

Model / REF:

1009-9002-000

Serial Numbers:

All Serial Numbers

GTIN:

00840682102322

Product: Amingo

Model / REF:

1009-9013-000

Serial Numbers:

All Serial Numbers

GTIN:

00840682102322

Product: Avance CS2 and Avance CS2 Pro

Model / REF:

1009-9050-000

1011-9050-000

1009-9002-000

1009-9212-000

Serial Numbers:

All Serial Numbers

GTIN:

00840682102322

Product: Aisys

Model / REF:

1011-9000-000

Serial Numbers:

All Serial Numbers

GTIN:

00840682102292

Product: Aisys CS2

Model / REF:

1011-9050-000

Serial Numbers:

All Serial Numbers

GTIN:

00840682102292

Product: Aisys CS2 with Et Control

Model / REF:

1011-9055-000

Serial Numbers:

All Serial Numbers

GTIN:

00195278588128

Product: Auxiliary Common Gas Outlet (ACGO) conversion/install kits

Variants: CONV KIT SCGO TO ACGO, ACGO ASSY FIELD INSTL

Model / REF:

1009-8249-000

1011-8071-000

Spare Part Numbers: 1009-8249-000, 1011-8071-000. Included as these kits are used to convert machines to the ACGO configuration.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95045

Status: Active

Manufacturer: Datex-Ohmeda, Inc.

Sold By: GE HealthCare; authorized medical device distributors

Manufactured In: United States

Units Affected: 10 products (20,097 units; 12,036 units; 10,338 units; 9,349 units; 77 units; 12,559 units; 4,790 units; 15,739 units; 92 units; 649 units)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Aespire, Avance, and Aisys anesthesia machines, along with conversion kits sold under names like CONV KIT SCGO TO ACGO and ACGO ASSY FIELD INSTL.

Check your device for model numbers Aespire 100, 7100, 7900, View, Avance, Amingo, Avance CS2, Aisys, or Aisys CS2. See the Affected Products section below for the full list of affected codes.

Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Contact GE HealthCare or your authorized medical device distributor for further instructions regarding device configuration and connection verification.

Call the FDA: 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional information.

Affected Products

Product: Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva

Model / REF:

1009-9000-000

1009-9101-000

1009-9004-000

Serial Numbers:

All Serial Numbers

GTIN:

00840682102261

All devices of the indicated products configured with the AGCO option are potentially affected.

Product: Aespire 100

GTIN:

00840682102261

Product: Aespire 7900

Model / REF:

1009-9012-000

Serial Numbers:

All Serial Numbers

GTIN:

00840682102261

All devices configured with the AGCO option are potentially affected.

Product: Aespire View

Model / REF:

1009-9212-000

Serial Numbers (1527):

1009-9212-000-117639

1009-9212-000-136105

1009-9212-000-518222

1009-9212-000-521025

1009-9212-000-552778

1009-9212-000-090755

1009-9212-000-059245

1009-9212-000-110073

1009-9212-000-203581

1009-9212-000-423283

1009-9212-000-419502

1009-9212-000-427555

1009-9212-000-460867

1009-9212-000-478499

1009-9212-000-109510

1009-9212-000-521303

1009-9212-000-097620

1009-9212-000-102602

1009-9212-000-520908

1009-9212-000-098765

1009-9212-000-076846

1009-9212-000-070149

1009-9212-000-189720

1009-9212-000-140832

1009-9212-000-036279

1009-9212-000-484467

1009-9212-000-520055

1009-9212-000-516124

1009-9212-000-182799

1009-9212-000-161253

1009-9212-000-121684

1009-9212-000-117998

1009-9212-000-499121

1009-9212-000-405786

1009-9212-000-425988

1009-9212-000-309943

1009-9212-000-045250

1009-9212-000-121264

1009-9212-000-478484

1009-9212-000-184939

1009-9212-000-513915

1009-9212-000-049292

1009-9212-000-467900

1009-9212-000-521309

1009-9212-000-243610

1009-9212-000-431587

1009-9212-000-089004

1009-9212-000-248292

1009-9212-000-308148

1009-9212-000-115588

GTIN:

00840682102285

All Serial Numbers for indicated model numbers are affected if configured with the AGCO option.

Product: Avance

Model / REF:

1009-9002-000

Serial Numbers:

All Serial Numbers

GTIN:

00840682102322

Product: Amingo

Model / REF:

1009-9013-000

Serial Numbers:

All Serial Numbers

GTIN:

00840682102322

Product: Avance CS2 and Avance CS2 Pro

Model / REF:

1009-9050-000

1011-9050-000

1009-9002-000

1009-9212-000

Serial Numbers:

All Serial Numbers

GTIN:

00840682102322

Product: Aisys

Model / REF:

1011-9000-000

Serial Numbers:

All Serial Numbers

GTIN:

00840682102292

Product: Aisys CS2

Model / REF:

1011-9050-000

Serial Numbers:

All Serial Numbers

GTIN:

00840682102292

Product: Aisys CS2 with Et Control

Model / REF:

1011-9055-000

Serial Numbers:

All Serial Numbers

GTIN:

00195278588128

Product: Auxiliary Common Gas Outlet (ACGO) conversion/install kits

Variants: CONV KIT SCGO TO ACGO, ACGO ASSY FIELD INSTL

Model / REF:

1009-8249-000

1011-8071-000

Spare Part Numbers: 1009-8249-000, 1011-8071-000. Included as these kits are used to convert machines to the ACGO configuration.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95045

Status: Active

Manufacturer: Datex-Ohmeda, Inc.

Sold By: GE HealthCare; authorized medical device distributors

Manufactured In: United States

Units Affected: 10 products (20,097 units; 12,036 units; 10,338 units; 9,349 units; 77 units; 12,559 units; 4,790 units; 15,739 units; 92 units; 649 units)

Distributed To: Nationwide