Philips Respironics, Inc. recalls Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides continuous or intermittent…
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…
Read the official notice →- Date
- 2022-02-02
- Country
- United States
- Brand
- Philips Respironics
- Product
- Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides continuous or intermittent…
- Classification
- Class I
- Units
- Worldwide Distribution: Distributed to the following US states: AR, CO, FL,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Philips Respironics recalls
- 2023-04-12
USPhilips Respironics, Inc. recalls Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, UDSX500S11F, UDSX700S11, UDSX700S11F, UFRX500S14.…
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Philips Respironics, Inc. recalls Trilogy EV300 Portable Electric Ventilator, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, CN2200X17B, BR2200X18B,…
The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO2 sensor may indicate a value…
FDA · DevicePhilips Respironics, Inc.Worldwide distribution. US Nationwide including Puerto Rico, and countries of…Official notice → - 2023-01-18
- US
Philips Respironics, Inc. recalls Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B, 1054260B, CA1054096B, BT1054260, 1054096B,…
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…
FDA · DevicePhilips Respironics, Inc.US Nationwide and Global Distribution to countries of: Australia, Brazil,…Official notice → - 2022-10-12
- US
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No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.
FDA · DevicePhilips Respironics, Inc.Worldwide distribution - US Nationwide distribution including in the states of…Official notice → - 2022-09-14
- US
Philips Respironics, Inc. recalls Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and…
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
FDA · DevicePhilips Respironics, Inc.Domestic: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA,…Official notice → - 2022-03-30
- US
Philips Respironics, Inc. recalls Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The device is intended to be used in home,…
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…
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