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Terminated

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.

FDA Recall Z-1065-2016 · Posted 2016-03-07

Recalling FirmPhilips Respironics
Recall StatusTerminated
Product CodeCBK
Date Initiated2016-01-18
Date Terminated2017-05-26
Product Quantity104,508 units

Reason for Recall

Software Issue

Firm 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.

Root Cause

Software design

Distribution Pattern

Nationwide Distribution including Puerto Rico and Internationally to the US Virgin Islands.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K093905TRILOGY 202 VENTILATORRespironics, Inc. · 2010-05-12K093416TRILOGY 200 VENTILATORRespironics, Inc. · 2010-01-29K083526TRILOGY 100 VENTILATORRespironics Inc., Sleep & Home Respiratory Group · 2009-03-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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