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U.S. Department of Health and Human Services

Class 1 Device Recall Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators

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  Class 1 Device Recall Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators see related information
Date Initiated by Firm June 12, 2018
Create Date March 18, 2022
Recall Status1 Open3, Classified
Recall Number Z-0785-2022
Recall Event ID 89584
510(K)Number K111610  
Product Classification Ventilator, continuous, facility use - Product Code CBK
Product 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.
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
Recalling Firm/
Manufacturer		 Philips Respironics, Inc.
1001 Murry Ridge Ln
Murrysville PA 15668-8517
Manufacturer 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 This 2018 correction has been superseded by the device removal and rework described in Philips Respironics 2021 recall action for the same devices.
FDA Determined
Cause 2		 Device Design
Action 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. A Field Communication for Trilogy Preventive Maintenance Update was distributed to customers 6/12/18. PRODUCT(S) AFFECTED All Trilogy models with Inlet Air Path Assembly PURPOSE / SCOPE This Field Communication announces: " The addition of the replacement of the Inlet Air Path Assembly and Removable Air Path Foam during the 10000 blower hour/24 month (whichever comes first) PM and 17,500-blower hour PM interval. " Trilogy Ventilator Maintenance Record revision to include the replacement date for the Air Inlet Path Assembly and Removable Air Path Foam. ACTION REQUIRED At both the 10000 blower hour/24 month (whichever comes first) and 17,500-blower hour PM intervals, the Inlet Air Path Assembly and Removable Air Path Foam are to be replaced. PROCEDURE For Inlet Air Path Assembly replacement procedures, refer to the Trilogy 100, 200, 202 & O2 Service & Technical Information Manual P/N 1002735 Section 11.2.3. For Removable Air Path Foam replacement procedures, refer to the Trilogy 100, 200, 202 & O2 Service & Technical Information Manual P/N 1002735 Section 11.2.4. IF you have any questions contact: Customer Service and Technical Support at 1-800-345-6443 or 724-387-4000 or email technical support at respironics.service@philips.com.
Quantity in Commerce 229,353 devices
Distribution Global Distribution. US Nationwide.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = RESPIRONICS, INC.
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