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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Home Healthcare

Philips Respironics, Inc.: OmniLab Advanced + Ventilators Recalled for Risk of Therapy Interruption

Agency Publication Date: May 23, 2024
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Summary

Philips Respironics is recalling approximately 9,388 OmniLab Advanced + Ventilator units in the U.S. because the devices may experience a sudden interruption or total loss of therapy when a 'Ventilator Inoperative' alarm occurs. This defect could cause the device to stop providing essential breathing support to patients. Consumers should contact their healthcare provider or the manufacturer immediately for further instructions and guidance on alternative treatment options.

Risk

If the ventilator fails and stops providing therapy, it can cause a patient to breathe insufficiently (hypoventilation), lead to dangerously low blood oxygen levels (hypoxemia), or cause high carbon dioxide levels in the blood (hypercarbia). These conditions can result in severe respiratory failure or potentially death.

What You Should Do

  1. Locate the identification label on your OmniLab Advanced + Ventilator to verify the Product Number and Serial Number.
  2. Check if your device matches the affected Product Numbers: 1111122, 1111123, 1111124, 1111125, 1111126, 1111127, 1111138, 1111141, 1111142, KR1111127, R1111122, R1111123, R1111124, U1111122, or U1111124.
  3. Cross-reference your device's unique Serial Number (e.g., beginning with L09, L10, L11, etc.) against the extensive list provided by the manufacturer to confirm if your specific unit is part of the recall.
  4. If your device is affected, contact your healthcare provider or physician immediately to discuss alternative therapy options and ensure your respiratory needs are met.
  5. Contact Philips Respironics at their customer service portal or via the contact information provided in the formal recall letter for further technical instructions or information on device repair/replacement.
  6. Call the FDA's medical device recall line at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding consumer safety.

Your Remedy Options

๐Ÿ“‹Other Action

Device correction and clinical guidance

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

Affected Products

Product: OmniLab Advanced + Ventilator
Model / REF:
1111122
1111123
1111124
1111125
1111126
1111127
1111138
1111141
1111142
KR1111127
R1111122
R1111123
R1111124
U1111122
U1111124
UPC Codes:
606959067813
606959067820
606959067837
606959067844
606959067851
606959067868
606959067875
606959067929
606959067905
606959067912
606959067981
606959067998
606959068001
00606959408777
606959077324
Lot Numbers:
L097964930206
L09796498BCD5
L111838125A56
L11249556238E
L097659502973
L097788972E7B
L102985833B41
L102985923310
L102986344432
L10298707061D
L09789213A3A2
L09789224FD75
L15541395F813
L16241342886B
L17903420D53A
L17903421C4B3
L155941900825
L1559419119AC
L15016678E5A9
L15016681FBA0
L09778211F6F7
L09778212C46C
L12600262AF76
L202202071744
L0976588485F3
L09765885947A
L098136050C6E
L100103448729
L097658884F9F
L097659050066

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94487
Status: Active
Manufacturer: Philips Respironics, Inc.
Sold By: Authorized Medical Device Distributors; Healthcare Providers
Manufactured In: United States
Units Affected: 9,388 US; 2,664 ROW
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 ยท 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.