Device product
Terumo Capiox NX19 Oxygenator (East Orientation), P/N: CXOT280 Exported only to Japan for inclusion into convenience kits that are sold only within the Japanese market
Z-2103-2019
Product summary
- Event
- Event 83240
- Status
- Terminated
- Classification
- Class II
- Quantity
- 78 units
- Official record key
device-enforcement:Z-2103-2019
Official wording
Reason: Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component
Code information: Lot Numbers: XA28, XC12, XC25, XD05, XD27
Distribution pattern: MI Foreign: Japan, Belgium
Derived failure modes
-
Unknown
Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component