Z-1065-2016Class II

Trilogy 100, Trilogy 200, Trilogy O2, Trilogy 202, Trilogy EC, Garbin, Garbin Plus Trilogy 100, Trilogy 200...

Name: Z-1065-2016 Trilogy 100, Trilogy 200, Trilogy O2, Trilogy 202, Trilogy EC, Garbin, Garbin Plus Trilogy 100, Trilogy 200...
Creator: Philips Respironics
Published: 2016-01-18
License: https://open.fda.gov/license/

Respironics, Inc. / initiated 2016-01-18 / Terminated / root cause: software

FDA source

Philips Respironics began a recall of Trilogy 100, Trilogy 200, Trilogy O2, Trilogy 202, Trilogy EC, Garbin, Garbin Plus Trilogy 100, Trilogy 200, Garbin, Garbin plus provides continuous or... on 2016-01-18. FDA classified it as Class II and gives the reason as "Software Issue". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1065-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-18
Posted: 2016-03-07
Terminated: 2017-05-26
Recalling firm: Respironics, Inc.
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.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: Software Issue
Root cause tag: software
FDA root cause: 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.
Product codes and lots: 11 digit S/N begginning with GV or TV; also TGY1D01463

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1065-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1065-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-16	2016-03-07

Product code CBK

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)