Device product
Terumo Capiox NX19 Oxygenator With Reservoir (West Orientation) P/N: 3CX*NX19RW
Z-2102-2019
Product summary
- Event
- Event 83240
- Status
- Terminated
- Classification
- Class II
- Quantity
- 52units
- Official record key
device-enforcement:Z-2102-2019
Official wording
Reason: Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component
Code information: Lot Numbers: XAl 1, XA28, XC07
Distribution pattern: MI Foreign: Japan, Belgium
Derived failure modes
-
Unknown
Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component