Device product
Cerelink ICP Monitor, Model Number 826820; intended for use as an interface between compatible strain-gauge type pressure transducers and standard physiological pressure monitoring systems.
Z-0124-2020
Product summary
- Event
- Event 83831
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 189
- Official record key
device-enforcement:Z-0124-2020
Official wording
Reason: There is a potential for a progressive decline in observed ICP readings of the monitor during use.
Code information: All systems
Distribution pattern: The products were distributed to the following US states: CA, CO, CT, FL, IN, NY, OK, PA, TX, WI, and WV. The products were distributed to the following foreign countries: Australia, Belgium.
Derived failure modes
-
Unknown
There is a potential for a progressive decline in observed ICP readings of the monitor during use.