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# Respironics Recalls OmniLab Ventilator
- URL: https://www.fdaweb.com/respironics-recalls-omnilab-ventilator/
- Published: 2024-05-24T12:00:00.000Z
- Updated: 2026-09-14T14:31:46.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5157058

Philips Respironics has recalled (Class 1) its OmniLab Advanced + Ventilator because the device may experience an interruption or loss of therapy in case of a ventilator inoperative alarm. An interruption/loss of therapy could lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death, a [recall notice](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=207300&ref=fdaweb.com) says. FDA says the malfunction is traced back to a device design issue.

Respironics mailed an “URGENT Medical Device Recall” letter 4/1 to describe the product problem and actions to be taken. The firm reminded customers to refer to the user manual and to perform a clinical assessment prior to placing a patient on the ventilator to ensure that:

- The device is appropriately set for patient requirements.
- Alternate ventilation equipment is available.
- Alternative monitoring is used where appropriate.

“Depending on the level of ventilatory support required, customers were advised to place patients on an alternate source of ventilation, the notice says.