Philips OmniLab Advanced + Ventilator May Experience Unexpected Therapy Loss
Philips OmniLab Advanced + Ventilators may experience an alarm condition that interrupts or stops therapy delivery. This interruption may lead to inadequate breathing support, low oxygen levels, and potentially fatal respiratory failure.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This device received an FDA Class I classification. Per the severity rubric, Class I recalls never score below 4 (Severe). While no deaths or injuries are explicitly reported, the potential for respiratory failure and death in a critical life-support device justifies the Severe classification.
Plain-English summary
Philips Respironics is recalling certain OmniLab Advanced + Ventilator models due to a potential malfunction that may cause a Ventilator Inoperative alarm condition and loss of therapy delivery.
When this alarm occurs, the device may stop delivering breathing therapy, potentially resulting in hypoventilation, hypoxemia (low blood oxygen), hypercarbia, respiratory failure or insufficiency, or potentially death. This is a serious risk for patients dependent on the device for life support.
Approximately 9,388 units were distributed in the United States and 2,664 units internationally, including Canada. The recalled devices can be identified by their product numbers (including 1111122, 1111123, 1111124, and others) and specific serial numbers listed in the FDA recall notice.
Patients and caregivers should contact Philips Respironics immediately for information about this recall and any necessary corrective actions.
The recalled product
- Product
- OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127 R1111122 R1111123 R1111124 U1111122 U1111124
- Manufacturer
- Philips Respironics, Inc.
- Category
- Medical Device — Ventilator
- Hazard
- therapy-interruption
- hypoventilation
- hypoxemia
- hypercarbia
- respiratory-failure
Distribution
Distributed nationwide across the United States.
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