FDA-Device2016-03-16Class II

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.

Philips Respironics
Hazard

Software Issue

Sold states
Nationwide Distribution including Puerto Rico and Internationally to the US Virgin Islands.
Affected count
104,508 units
Manufactured in
1740 Golden Mile Hwy, N/A, Monroeville, PA, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1065-2016

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