Reported Mar 30, 2022 · Ongoing
Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The device is intended to be used in…
Philips Respironics, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Respironics, Inc. · 1001 Murry Ridge Ln · Murrysville, PA · 15668-8517
Is this the product you have?
- Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator.
- Lot codes and dates
- All device serial numbers. Material Numbers
91 of 91 codes
10400011054096105409710542601054655105818011198671040001B1054096B1054096NB1054097B1054260B1054655B1054655TP1054655TPV1058180BAU1054096AU1054096BBR1054096BT1054096BT1054260CA1054096CA1054096BCN1054096IT1054096BKO1054096KR1054096LA1054096LG1054096R1054096R1054096BR1054097R1054097BR1054260R1054260BR1054655R1054655BR1054655TPR1054655TPVR1119867RSL1054260RSL1054260BRTO1054260RTO1054260BU1054096U1054096BU1054097U1054097BU1054260U1054260BU1054655RBR1054096RTO1119867103280010328021032804104000210400051032800B1032802B
- All device serial numbers. Material Numbers
- Amount recalled
- 229,353 devices
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
In 2018, Philips Respironics added foam replacement to the preventive maintenance schedule for these devices after discovering the polyester-based polyurethane (PE-PUR) foam may degrade into particles. This 2018 correction has been superseded by the device removal and rework described in Philips Respironics 2021 recall action for the same devices.
Using this product could cause serious injury, illness or death — stop using it now.
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