Philips Respironics recalls

Philips Respironics appears in 94 official U.S. recall notices indexed by RecallRadar.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

• Philips Respironics DreamWear Full Face Mask
  FDA Device · Class I · 2022-10-12 · Philips Respironics
  Reason: No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.
• Therapy Mask 3100 NC/SP
  FDA Device · Class I · 2022-10-12 · Philips Respironics
  Reason: No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.
• Wisp and Wisp Youth Nasal Mask
  FDA Device · Class I · 2022-10-12 · Philips Respironics
  Reason: No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.
• Philips Respironics Amara View Minimal Contact Full-Face Mask
  FDA Device · Class I · 2022-10-12 · Philips Respironics
  Reason: No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.
• DreamWisp Nasal Mask with Over the Nose Cushion
  FDA Device · Class I · 2022-10-12 · Philips Respironics
  Reason: No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.
• Philips OmniLab Advanced + with Heated Tube Humidifier, Rx Only
  FDA Device · Class I · 2022-09-14 · Philips Respironics
  Reason: Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
• Philips BiPAP V30 Auto, Rx Only
  FDA Device · Class I · 2022-09-14 · Philips Respironics
  Reason: Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
• Philips BiPAP A30, Rx Only
  FDA Device · Class I · 2022-09-14 · Philips Respironics
  Reason: Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
• Philips BiPAP A40, Rx Only
  FDA Device · Class I · 2022-09-14 · Philips Respironics
  Reason: Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
• Philips OmniLab Advanced+ Intl (Flow Gen), Rx Only
  FDA Device · Class I · 2022-09-14 · Philips Respironics
  Reason: Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
• Philips OmniLab Advanced+, Rx Only
  FDA Device · Class I · 2022-09-14 · Philips Respironics
  Reason: Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
• Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The device is intended to be used in home, institution/hospit…
  FDA Device · Class I · 2022-03-30 · Philips Respironics
  Reason: 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 correct…
• Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257 The Trilogy Evo ventilator provides continuous or intermit…
  FDA Device · Class I · 2022-02-02 · Philips Respironics
  Reason: 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 mat…
• Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides continuous or intermittent positi…
  FDA Device · Class I · 2022-02-02 · Philips Respironics
  Reason: 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 mat…
• Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B
  FDA Device · Class II · 2021-08-25 · Philips Respironics
  Reason: Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second issue is described as "Pressure Dr…
• Trilogy Evo, Product numbers BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, EE2110X15B, ES2110X15B, EU2110X15B, EU2110X19, FR2110X14B, GB2…
  FDA Device · Class II · 2021-08-25 · Philips Respironics
  Reason: Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second issue is described as "Pressure Dr…
• Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA2100X15B, IN2100X15B,…
  FDA Device · Class II · 2021-08-25 · Philips Respironics
  Reason: Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second issue is described as "Pressure Dr…
• Trilogy Evo Universal, Product number DS2000X11B
  FDA Device · Class II · 2021-08-25 · Philips Respironics
  Reason: Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second issue is described as "Pressure Dr…
• DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+ Continuous Ventilator, No…
  FDA Device · Class I · 2021-07-21 · Philips Respironics
  Reason: The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.
• Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators
  FDA Device · Class I · 2021-07-21 · Philips Respironics
  Reason: The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.
• Philips Respironics E30 with Humidifier, Continuous Ventilator, Minimum Ventilatory Support, Facility Use
  FDA Device · Class I · 2021-07-21 · Philips Respironics
  Reason: The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.
• SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto Noncontinuous Ventilators The Philips Respironic…
  FDA Device · Class I · 2021-07-21 · Philips Respironics
  Reason: The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.
• A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous Ventilator, Minimum Ventilatory Support, Facility Use
  FDA Device · Class I · 2021-07-21 · Philips Respironics
  Reason: The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.
• A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting
  FDA Device · Class I · 2021-07-21 · Philips Respironics
  Reason: The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.
• BiPAP A40, China: Continuous ventilator, non-life-supporting
  FDA Device · Class II · 2021-06-02 · Philips Respironics
  Reason: Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not normally present creating a potentia…
• BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting
  FDA Device · Class II · 2021-06-02 · Philips Respironics
  Reason: Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not normally present creating a potentia…
• BiPAP V30 Auto, US market: Continuous ventilator, non-life-supporting
  FDA Device · Class II · 2021-06-02 · Philips Respironics
  Reason: Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not normally present creating a potentia…
• BiPAP A40, Brazil: Continuous ventilator, non-life-supporting
  FDA Device · Class II · 2021-06-02 · Philips Respironics
  Reason: Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not normally present creating a potentia…
• BiPAP A30, Brazil: Continuous ventilator, non-life-supporting
  FDA Device · Class II · 2021-06-02 · Philips Respironics
  Reason: Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not normally present creating a potentia…
• BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting
  FDA Device · Class II · 2021-06-02 · Philips Respironics
  Reason: Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not normally present creating a potentia…
• Trilogy EVO Ventilator, Iberia - Model Number: ES2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.…
  FDA Device · Class I · 2020-02-26 · Philips Respironics
  Reason: Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an inco…
• Trilogy EVO Ventilator, France - Model Number: FR2110X14B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.…
  FDA Device · Class I · 2020-02-26 · Philips Respironics
  Reason: Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an inco…
• Garbin EVO Ventilator, Linde - Model Number: LD2110X23B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5…
  FDA Device · Class I · 2020-02-26 · Philips Respironics
  Reason: Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an inco…
• Trilogy EVO Ventilator, 02 - Italy - Model Number: IT2100X21B Trilogy Evo is intended for pediatric through adult patients weighing at leas…
  FDA Device · Class I · 2020-02-26 · Philips Respironics
  Reason: Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an inco…
• Trilogy EVO Ventilator, 02 - Iberia - Model Number: ES2100X15B Trilogy Evo is intended for pediatric through adult patients weighing at lea…
  FDA Device · Class I · 2020-02-26 · Philips Respironics
  Reason: Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an inco…
• Trilogy EVO Ventilator, EU - Model Number: EU2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg
  FDA Device · Class I · 2020-02-26 · Philips Respironics
  Reason: Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an inco…
• Trilogy EVO Ventilator, 02 - International - Model Number: IN2100X15B Trilogy Evo is intended for pediatric through adult patients weighing…
  FDA Device · Class I · 2020-02-26 · Philips Respironics
  Reason: Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an inco…
• Trilogy EVO Ventilator, 02 - EU - Model Number: EU2100X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2…
  FDA Device · Class I · 2020-02-26 · Philips Respironics
  Reason: Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an inco…
• LifeVent EVO Ventilator, 02 - Model Number: SP2100X26B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg
  FDA Device · Class I · 2020-02-26 · Philips Respironics
  Reason: Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an inco…
• Trilogy EVO Ventilator, Nordics - Model Number: ND2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2…
  FDA Device · Class I · 2020-02-26 · Philips Respironics
  Reason: Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an inco…
• Trilogy EVO Ventilator, Germany - Model Number: DE2110X13B Trilogy Evo is intended for pediatric through adult patients weighing at least 2…
  FDA Device · Class I · 2020-02-26 · Philips Respironics
  Reason: Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an inco…
• Trilogy EVO Ventilator, Great Britain - Model Number: GB2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at l…
  FDA Device · Class I · 2020-02-26 · Philips Respironics
  Reason: Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an inco…
• Trilogy EVO Ventilator, International, Model Number IN2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at lea…
  FDA Device · Class I · 2020-02-26 · Philips Respironics
  Reason: Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an inco…
• Trilogy 100, Trilogy 200, Trilogy O2, Trilogy 202, Trilogy EC, Garbin, Garbin Plus Trilogy 100, Trilogy 200, Garbin, Garbin plus provides c…
  FDA Device · Class II · 2016-03-16 · Philips Respironics
  Reason: Software Issue