Philips Respironics recalls BiPAP A40 Ventilators with specific part numbers due to potential interruption of therapy during ventilator inoperative alarms, which may lead to hypoventilation, hypoxemia, hypercarbia, or respiratory failure in vulnerable patients.
Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.
Philips Respironics is recalling BiPAP A40 Ventilators with specific part numbers (US and OUS) because they can experience therapy interruptions during ventilator inoperative alarms. This risk could lead to hypoventilation, hypoxemia, hypercarbia, or even respiratory failure in patients who rely on these devices.
The ventilators may stop delivering therapy when the inoperative alarm sounds, which can cause patients to experience hypoventilation (inadequate breathing), hypoxemia (low oxygen levels), hypercarbia (high carbon dioxide levels), or respiratory failure. This risk is highest for patients who depend on the device for life support.
Patients using BiPAP A40 Ventilators with the listed part numbers in the US and overseas markets are most at risk. This includes individuals with respiratory conditions requiring continuous ventilator support.
Check your BiPAP A40 Ventilator for part numbers listed in the US (1111169) or overseas (1111170-1111174, and other specific numbers). The device may also have a serial number or material number that matches the provided list.
Look for the part numbers listed in the recall (US: 1111169, OUS: 1111170-1111174) or serial numbers in the provided list to confirm if your device is affected.
If your device is affected, contact Philips Respironics directly for instructions on how to return or repair the device.
The affected part numbers include US: 1111169 and OUS: 1111170-1111174, with additional specific numbers listed in the recall notice.
No, the recall does not require immediate discontinuation of use. However, if your device is affected, you should contact Philips Respironics for guidance on next steps.
Check your device's part number or serial number against the list provided in the recall notice. Affected devices have specific part numbers listed in the US (1111169) or overseas (1111170-1111174) and other serial numbers.
We’ve drafted a message you can send Philips Respironics to request your refund or repair — edit it as you like.
Subject: Recall Z-1813-2024 — Philips Respironics Philips Respironics Hello, I own a Philips Respironics that is covered by recall Z-1813-2024 from Philips Respironics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.