Recall Z-1065-2016 ยท CBK Ventilator, Continuous, Facility Use
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.
| Date | Mar 7, 2016 (initiated Jan 18, 2016) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |