Device 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.
Z-1065-2016
Product summary
- Event
- Event 73177
- Status
- Terminated
- Classification
- Class II
- Quantity
- 104,508 units
- Official record key
device-enforcement:Z-1065-2016
Official wording
Reason: Software Issue
Code information: 11 digit S/N begginning with GV or TV; also TGY1D01463
Distribution pattern: Nationwide Distribution including Puerto Rico and Internationally to the US Virgin Islands.
Derived failure modes
-
Device software or design
Software Issue