Z-0785-2022 Class I Ongoing
FDA device recall Z-0785-2022 was initiated by Philips Respironics, Inc. on Jun 12, 2018 and is designated Class I. Reason for recall: 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… The recall status is ongoing. Affected quantity: 229,353 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 30, 2022
- Initiation Date
- Jun 12, 2018
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 229,353 devices
Product Description
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.
Reason for Recall
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 This 2018 correction has been superseded by the device removal and rework described in Philips Respironics 2021 recall action for the same devices.
Distribution Pattern
Global Distribution. US Nationwide.
Code Information
All device serial numbers. Material Numbers 1040001 1054096 1054097 1054260 1054655 1058180 1119867 1040001B 1054096B 1054096NB 1054097B 1054260B 1054655B 1054655TP 1054655TPV 1058180B AU1054096 AU1054096B BR1054096 BT1054096 BT1054260 CA1054096 CA1054096B CN1054096 IT1054096B KO1054096 KR1054096 LA1054096 LG1054096 R1054096 R1054096B R1054097 R1054097B R1054260 R1054260B R1054655 R1054655B R1054655TP R1054655TPV R1119867 RSL1054260 RSL1054260B RTO1054260 RTO1054260B U1054096 U1054096B U1054097 U1054097B U1054260 U1054260B U1054655 RBR1054096 RTO1119867 1032800 1032802 1032804 1040002 1040005 1032800B 1032802B 1032804B 1032804TP 1032804TPV 1040002B 1040005B 1125564B AU1032800 AU1032800B BR1032800 CA1032800 CA1032800B IT1032800B KO1032800 KR1032800 LA1032800 LG1032800 R1032800 R1032802 R1032804 R1032804B R1032804TP R1032804TPV R1040005 R1040005B RTO1040005B SP1032800B U1032800 U1032802 U1032804 U1040005 U1040005B
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0785-2022
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026