Trilogy 100, Trilogy 200, Trilogy O2, Trilogy 202 recallZ-1065-2016 · Philips Respironics · initiated Jan 18, 2016
Class II Terminated All recalls posted in March 2016
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Philips Respironics or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Software Issue
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-1065-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jan 18, 2016
- Posted by the FDA
- Mar 7, 2016
- Recalling firm
- Philips Respironics
- Quantity
- 104,508 units
- Product code
- CBK
- FDA submissions
- K083526, K093416, K093905
- Distribution
- Nationwide Distribution including Puerto Rico and Internationally to the US Virgin Islands.
Product description
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 (models, lots, serial numbers)
11 digit S/N begginning with GV or TV; also TGY1D01463
Other devices under the same FDA submission
44 devices cleared under K083526, K093416, K093905 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Trilogy Trilogy100 Ventilator, United StatesRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE92 deaths8,161 reports
- Trilogy Trilogy100 Ventilator, InternationalRespironics, Inc. · Oximeter8 deaths2,493 reports
- Trilogy 00Respironics, Inc. · CONTINUOUS, VENTILATOR, HOME USE15 deaths2,059 reports
- Trilogy Trilogy O2 Ventilator JapanRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE7 deaths1,900 reports
- Trilogy Trilogy 202 Ventilator, United StatesRespironics, Inc. · Oximeter2 deaths1,594 reports
- Trilogy Trilogy 202 Ventilator InternationalRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE11 deaths1,564 reports
- Trilogy Trilogy100 Ventilator, GermanyRespironics, Inc. · Oximeter696 reports
- Trilogy Trilogy 100 Ventilator, ChinaRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE1 death447 reports
- Trilogy100 Ventilator, Japan-RentalRespironics, Inc. · Medical device data system2 deaths334 reports
- Trilogy Trilogy 202 Ventilator, ChinaRespironics, Inc. · Oximeter1 death304 reports
- Trilogy Trilogy100 Ventilator, Latin AmericaRespironics, Inc. · Oximeter154 reports
- Trilogy 100 Trilogy100 Ventilator, Bluetooth, ItalyRespironics, Inc. · Medical device data system146 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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