Z-1395-2022 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 3, 2022
- Initiation Date
- June 22, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,210 units
Product Description
CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor.
Reason for Recall
Integra has received complaints associated with ICP readings drifting to -50 mmHg (out-of-range) and may manifest an error message "sensor or extension cable failure!" The firm has found that this is caused by electrical interference from a component of the monitor's circuit board and from the environment.
Distribution Pattern
Worldwide Distribution: US nationwide, Australia, New Zealand, Canada, Hong Kong, Pakistan, Georgia, Saudi Arabia, Israel, South Africa, United Arab Emirates, Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Latvia, Lithuania, Netherlands, Norway, Portugal, Switzerland, Spain, Sweden, Slovakia, and United Kingdom.
Code Information
UDI-DI- 10381780533778; All serial numbers.