Philips Respironics recalls V60 Plus Ventilators with software versions 3.00 and 3.10 due to potential oxygen desaturation. Affected units have specific serial numbers and model numbers. Users should contact Philips for a software update.
It has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 and 3.10), that includes a designed safety mechanism that limits the amount of pressure that can be delivered to a patient, in situations where the system pressure reaches the maximum limit and sounds the "Cannot Reach Target Flow" alarm , the system will reduce pressure and simultaneously decreasing the flow rate to a level below what was set by the clinicians. If the reason for the increase in pressure is not resolved, the ventilator will continue to provide the lower flow rate, which result in patients experiencing oxygen desaturation which can be characterized as moderate or severe hypoxemia.
Philips Respironics is recalling V60 Plus Ventilators with software versions 3.00 and 3.10 because they can cause oxygen desaturation in patients. This happens when the ventilator reduces flow rate after triggering a safety alarm, leading to moderate or severe hypoxemia.
The ventilator's safety mechanism limits pressure but can reduce flow rate to below the set level when it triggers a 'Cannot Reach Target Flow' alarm. If the underlying issue isn't resolved, the ventilator continues providing lower flow rates, causing patients to experience oxygen desaturation (moderate or severe hypoxemia).
Patients using the V60 Plus Ventilator with software versions 3.00 and 3.10 for respiratory support are at risk. Healthcare providers and patients with conditions like sleep apnea or respiratory failure are most affected.
Check for the V60 Plus Ventilator with software versions 3.00 or 3.10. Model numbers include P/N 1138747 and 1137276. System serial numbers and UDI codes are listed in the recall notice.
Verify your ventilator's software version by checking the device settings or documentation. If it is version 3.00 or 3.10, it is affected.
Reach out to Philips Respironics for instructions on updating the software to a safe version or returning the device.
The affected software versions are 3.00 and 3.10.
Check the model number (P/N 1138747 or 1137276) and software version. Affected units have specific system serial numbers and UDI codes listed in the recall notice.
Yes, the ventilator can cause moderate or severe hypoxemia if the underlying issue isn't resolved after triggering the safety alarm.
We’ve drafted a message you can send Philips Respironics to request your refund or repair — edit it as you like.
Subject: Recall Z-2074-2021 — Philips Respironics Philips Respironics Hello, I own a Philips Respironics that is covered by recall Z-2074-2021 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.
