Trilogy 100, Trilogy 200, Trilogy O2, Trilogy 202, Trilogy EC, Garbin, Garbin Plus Trilogy 100, Trilogy 200, Garbin, Gar
FDA device recall Z-1065-2016 · posted 2016-03-07 · Terminated
Recall details
- Recalling firm
- Philips Respironics
- Reason for recall
- Software Issue
- Action taken
- 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
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 104,508 units
- Distribution
- Nationwide Distribution including Puerto Rico and Internationally to the US Virgin Islands.
- Date initiated
- 2016-01-18
- Date posted
- 2016-03-07
- Date terminated
- 2017-05-26
- Location
- Monroeville, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRILOGY 202 VENTILATOR (K093905) | Respironics, Inc. | 2010-05-12 |
| TRILOGY 200 VENTILATOR (K093416) | Respironics, Inc. | 2010-01-29 |
| TRILOGY 100 VENTILATOR (K083526) | Respironics Inc., Sleep & Home Respiratory Group | 2009-03-13 |