Z-0124-2020 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 23, 2019
- Initiation Date
- September 12, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 189
Product Description
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.
Reason for Recall
There is a potential for a progressive decline in observed ICP readings of the monitor during use.
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.
Code Information
All systems