Device product
GENOSYL DS (Delivery System) console, for use as a vasodilator.
Z-2587-2021
Product summary
- Event
- Event 88558
- Status
- Completed
- Classification
- Class I
- Quantity
- 120 consoles (3 consoles affected)
- Official record key
device-enforcement:Z-2587-2021
Official wording
Reason: Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen dioxide (NO2) instead of nitric oxide (NO).
Code information: Model Number: 601588-01, Serial Numbers G0294 (UDI (01)00850000962026(11)200728(21)G0294); G0378 (UDI (01)00850000962026(11)200917(21)G0378); and MA000065 (UDI (01)00850000962026(11)210511(21)MA000065)
Distribution pattern: Distributed within US to Texas and Illinois.
Derived failure modes
-
Manufacturing or process control
Manufacturing defect