Philips Respironics, Inc. recalls
7 recalls on record · 7 rated Critical · FDA
Every recall we have on record for Philips Respironics, Inc., compiled from federal safety data. Check the hazard, the remedy, and how serious each one is, and always confirm on the official notice.
Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous…
Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use…
Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
BiPAP V30 Auto Ventilator, Part Number 1111178
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.
Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ventilator for…
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60…
Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of function.
Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B,…
The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which could result in a reduction in delivered therapy volume or pressure and could cause the device to alarm.
Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo…
Philips has identified a specific lot of non-conforming material manufactured by one of its suppliers. A Philips supplier incorrectly used polyester-based polyurethane (PE-PUR) sound abatement foam, a non-conforming material in the devices and repair kits. PE-PUR foam may degrade into particles which may enter the device s air pathway and be ingested or inhaled by the user. The foam degradation may be exacerbated by use of unapproved cleaning methods such as unapproved ozone cleaners, and the PE-PUR foam may off-gas certain chemicals during initial use of the device.