Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10 may cause oxygen desaturation due to a safety mechanism that reduces flow rate when pressure reaches maximum limit. Affected units have specific model numbers and serial codes.
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 V60 Ventilators with software versions 3.00 and 3.10 may cause oxygen desaturation if the system pressure reaches its maximum limit. This can lead to moderate or severe hypoxemia in patients using the device. The issue occurs when the ventilator reduces flow rate after sounding a 'Cannot Reach Target Flow' alarm, but continues to provide lower flow rates if the pressure problem isn't resolved.
The ventilator's safety mechanism is designed to reduce pressure and flow rate when system pressure reaches maximum limit, triggering a 'Cannot Reach Target Flow' alarm. If the underlying pressure issue isn't resolved, the ventilator continues to provide lower flow rates than intended, causing patients to experience oxygen desaturation (moderate or severe hypoxemia).
Patients using the Respironics V60 Ventilator with software versions 3.00 and 3.10 for mechanical ventilation. Those with respiratory conditions requiring assist ventilation are most at risk.
Check if your ventilator has software versions 3.00 or 3.10. Look for model numbers P/N 1053613-1076716 and serial codes listed in the record. The system serial numbers are also provided in the record.
Verify your ventilator's software version by checking the device settings or manual.
Reach out to Respironics California, LLC for guidance on whether your unit is affected and next steps.
Software versions 3.00 and 3.10.
Check for model numbers P/N 1053613-1076716 and software versions 3.00 or 3.10. The system serial numbers are listed in the recall record.
No, but you should check the software version and contact Respironics California, LLC for guidance.
We’ve drafted a message you can send Trsmima to request your refund or repair — edit it as you like.
Subject: Recall Z-2073-2021 — Trsmima Trsmima Hello, I own a Trsmima that is covered by recall Z-2073-2021 from Trsmima. 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.
