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U.S. Department of Health and Human Services

Class 2 Device Recall Ventilator, continuous, lifesupporting; Ventilator, continuous, facility use

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  Class 2 Device Recall Ventilator, continuous, lifesupporting; Ventilator, continuous, facility use see related information
Date Initiated by Firm January 18, 2016
Date Posted March 07, 2016
Recall Status1 Terminated 3 on May 26, 2017
Recall Number Z-1065-2016
Recall Event ID 73177
510(K)Number K083526  K093416  K093905  
Product Classification Ventilator, continuous, facility use - Product Code CBK
Product Trilogy 100, Trilogy 200, Trilogy O2, Trilogy 202,
Trilogy EC, Garbin, Garbin Plus

Trilogy 100, Trilogy 200, Garbin, Garbin plus provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.
Code Information 11 digit S/N begginning with GV or TV; also TGY1D01463
Recalling Firm/
Philips Respironics
1740 Golden Mile Hwy
Monroeville PA 15146-2012
For Additional Information Contact
Manufacturer Reason
for Recall
Software Issue
FDA Determined
Cause 2
Software design
Action Philips Respironics has determined that affected devices may continue to be used in accordance with the device Instructions for Use and the Field Safety Notification that is being issued to customers. Philips Respironics will be providing a software update for affected devices free of charge. Customers will be notified by mail when the software update is available for download. For further questions please call ( 724 ) 387-7500.
Quantity in Commerce 104,508 units
Distribution Nationwide Distribution including Puerto Rico and Internationally to the US Virgin Islands.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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.