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

• Date Initiated by Firm: June 14, 2021
• Date Posted: July 15, 2021
• Recall Status: Open, Classified
• Recall Number: Z-1956-2021
• Recall Event ID: 88071
• 510(K)Number: K083526 K093416 K111610
• Product Classification: Ventilator, continuous, facility use - Product Code CBK
• Product: Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators.
• Code Information: All Devices manufactured before 26 April 2021, 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
• For Additional Information Contact: 724-733-0200
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Device Design
• Action: Urgent Medical Device Recall letters were sent to customers starting 6/14/21. 1. Do not stop or alter your prescribed therapy until you have talked to your physician. Your physician may evaluate if the benefit outweighs the risks. 2. If your physician determines that you must continue using this device, use an inline bacterial filter. Your Instructions for Use has guidance on installation. 3. Register your device on www.philips.com/src-update or call 1-877-907-7508. An updated URGENT: Medical Device Recall notification letter was issued on 11/16/21. 1. Do not stop or change ventilator use until you have talked to your health care provider. If patients requiring a ventilator for life-sustaining therapy have no alternate, or therapy disruption is unacceptable, the HCP may determine if the benefit of continued use of these ventilator devices outweighs the potential risks identified in the recall letter. 2. Talk to your HCP about using an inline bacterial filter to help filter out foam particles. Instructions for Use has guidance on installation. At this time, the FDA does not have evidence of the safety and effectiveness of a filter for mitigating the foam risks, and evaluation is ongoing. Filters will not reduce exposure to chemicals from the PE-PUR foam. Filters may increase air flow resistance and affect ventilator performance. Monitor for accumulation of foam debris in the filter or resistance-related problems in the breathing circuit after filter placement. 3. Report any problems with a device through the FDA MedWatch Voluntary Reporting Form. 4. Register your device on the recall website www.philips.com/src-update with your device Serial Number, or call 1-877-907-7508. Devices should be serviced only by qualified technicians. There are no user serviceable parts. Attempts to remove the sound abatement foam may render the device permanently inoperative. Devices damaged due to foam removal attempts will not be able to be remediated.
• Quantity in Commerce: 255810
• Distribution: Worldwide distribution including US Nationwide, Argentina, Australia, Brazil, Canada, China, France, Germany, Italy, Japan, Korea, and Latin America.
• 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., SLEEP & HOME RESPIRATORY GROUP; 510(K)s with Product Code = CBK and Original Applicant = RESPIRONICS, INC.