GE Medical Systems, LLC: Tec 6 Plus and Tec 800 Series Anesthesia Vaporizers Recalled for Low Output

Agency Publication Date: January 7, 2025

Summary

Approximately 13,058 GE Medical Systems Tec 6 Plus and Tec 800 series anesthesia vaporizers are being recalled due to a manufacturing defect. The issue causes the devices to deliver less anesthetic agent to patients than what is indicated on the vaporizer's dial setting. These critical medical devices are used in healthcare settings globally to provide sedation during surgical procedures.

Risk

If the vaporizer delivers a lower dose of anesthetic than intended, the patient may not be sufficiently sedated during surgery, leading to unintended awareness or inadequate pain control. This failure could result in patient trauma or the need for immediate medical intervention during a procedure.

What You Should Do

Check your medical equipment for the following models: Tec 6 Plus, Tec 820 ISO, Tec 820 SEV, Tec 850 ISO, and Tec 850 SEV Anesthesia Vaporizers.
Verify your specific unit by matching the Reference (REF) or Global Trade Item Number (GTIN) and the Serial Number against the extensive list of over 13,000 affected units provided in the recall notice.
Identify the Serial Numbers which are listed by model, such as those beginning with 'AESC', 'SQAC', 'SQAD', 'SQBC', or 'SQBD'.
Contact your healthcare provider or the manufacturer, GE Medical Systems, LLC, at their Waukesha, Wisconsin headquarters to receive specific service instructions and to arrange for any necessary corrective actions.
Medical facilities should follow internal protocols for reporting device failures or output inaccuracies and should monitor patients closely if these devices remain in use pending manufacturer service.
For further questions or technical assistance, contact the FDA directly at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer correction/instruction following notification letter.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Tec 6 Plus Anesthesia Vaporizer

Model / REF:

1107-9601-000

1107-9602-000

1107-9603-000

1107-9604-000

1107-9610-000

1107-9612-000

1107-9616-000

1107-9617-000

2066835-001

2069767-001

2078800-001

2091008-001

2091009-001

M1098876

M1145610

M1220023

M1220854

M1221495

M1233992

UPC Codes:

0084068211253

00840682112659

00840682112574

00840682112925

00840682112864

00840682113236

00840682113069

00840682112666

00840682112857

00840682112505

00840682112512

00840682112437

00840682112802

00840682112710

00840682112765

00840682112789

00840682112826

00840682115902

00840682112451

Lot Numbers:

Serial Numbers: AESC31001 through AESC30013 (See source for full list of 1573 IDs)

Product: Tec 820 ISO Anesthesia Vaporizer

Model / REF:

1177-9820-ISO

UPC Codes:

00840682124744

Lot Numbers:

Serial Numbers: SQAD01037 through SQAD01042 (644 units)

Product: Tec 820 SEV Anesthesia Vaporizer

Model / REF:

1177-9820-SEV

UPC Codes:

00840682124720

Lot Numbers:

Serial Numbers: SQBC04329 through SQBD01418 (928 units)

Product: Tec 850 ISO Anesthesia Vaporizer

Model / REF:

1177-9850-ISO

UPC Codes:

00840682124751

Lot Numbers:

Serial Numbers: SQAC00742 through SQAD00473 (1594 units)

Product: Tec 850 SEV Anesthesia Vaporizer

Model / REF:

1177-9850-SEV

UPC Codes:

00840682124737

Lot Numbers:

Serial Numbers: SQBC03462 through SQBD04361 (8319 units)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95855

Status: Active

Manufacturer: GE Medical Systems, LLC

Sold By: GE Medical Systems, LLC; Authorized medical device distributors

Manufactured In: United States

Units Affected: 5 products (1573 units; 644 units; 928 units; 1594 units; 8319 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

Check your medical equipment for the following models: Tec 6 Plus, Tec 820 ISO, Tec 820 SEV, Tec 850 ISO, and Tec 850 SEV Anesthesia Vaporizers.

Verify your specific unit by matching the Reference (REF) or Global Trade Item Number (GTIN) and the Serial Number against the extensive list of over 13,000 affected units provided in the recall notice.

Identify the Serial Numbers which are listed by model, such as those beginning with 'AESC', 'SQAC', 'SQAD', 'SQBC', or 'SQBD'.

Contact your healthcare provider or the manufacturer, GE Medical Systems, LLC, at their Waukesha, Wisconsin headquarters to receive specific service instructions and to arrange for any necessary corrective actions.

Medical facilities should follow internal protocols for reporting device failures or output inaccuracies and should monitor patients closely if these devices remain in use pending manufacturer service.

For further questions or technical assistance, contact the FDA directly at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Affected Products

Product: Tec 6 Plus Anesthesia Vaporizer

Model / REF:

1107-9601-000

1107-9602-000

1107-9603-000

1107-9604-000

1107-9610-000

1107-9612-000

1107-9616-000

1107-9617-000

2066835-001

2069767-001

2078800-001

2091008-001

2091009-001

M1098876

M1145610

M1220023

M1220854

M1221495

M1233992

UPC Codes:

0084068211253

00840682112659

00840682112574

00840682112925

00840682112864

00840682113236

00840682113069

00840682112666

00840682112857

00840682112505

00840682112512

00840682112437

00840682112802

00840682112710

00840682112765

00840682112789

00840682112826

00840682115902

00840682112451

Lot Numbers:

Serial Numbers: AESC31001 through AESC30013 (See source for full list of 1573 IDs)

Product: Tec 820 ISO Anesthesia Vaporizer

Model / REF:

1177-9820-ISO

UPC Codes:

00840682124744

Lot Numbers:

Serial Numbers: SQAD01037 through SQAD01042 (644 units)

Product: Tec 820 SEV Anesthesia Vaporizer

Model / REF:

1177-9820-SEV

UPC Codes:

00840682124720

Lot Numbers:

Serial Numbers: SQBC04329 through SQBD01418 (928 units)

Product: Tec 850 ISO Anesthesia Vaporizer

Model / REF:

1177-9850-ISO

UPC Codes:

00840682124751

Lot Numbers:

Serial Numbers: SQAC00742 through SQAD00473 (1594 units)

Product: Tec 850 SEV Anesthesia Vaporizer

Model / REF:

1177-9850-SEV

UPC Codes:

00840682124737

Lot Numbers:

Serial Numbers: SQBC03462 through SQBD04361 (8319 units)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95855

Status: Active

Manufacturer: GE Medical Systems, LLC

Sold By: GE Medical Systems, LLC; Authorized medical device distributors

Manufactured In: United States

Units Affected: 5 products (1573 units; 644 units; 928 units; 1594 units; 8319 units)

Distributed To: Nationwide