FDA Medical Device Recalls (openFDA)
Philips Respironics: 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.
- Recall number
- Z-1065-2016
- Recalling firm
- Philips Respironics
- 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.
- Status
- Terminated
- Initiated
- 2016-01-18
- Posted
- 2016-03-07
- Terminated
- 2017-05-26
- Reason
- Software Issue
- 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
- 104,508 units
- Distribution
- Nationwide Distribution including Puerto Rico and Internationally to the US Virgin Islands.
- Lot, serial or model codes
- 11 digit S/N begginning with GV or TV; also TGY1D01463
- 510(k) numbers
- ["K083526","K093416","K093905"]
- PMA numbers
- not on file
- Product code
- CBK
- Firm FEI
- 3007871739
- Firm city
- Monroeville
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28