Device product
Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE
Z-2101-2019
Product summary
- Event
- Event 83240
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16 units
- Official record key
device-enforcement:Z-2101-2019
Official wording
Reason: Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component
Code information: Lot Number: WP17
Distribution pattern: MI Foreign: Japan, Belgium
Derived failure modes
-
Unknown
Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component