FDA-Device2022-08-03Class I
CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor.
Integra LifeSciences Corp.
Hazard
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.
Sold states
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.
Affected count
1,210 units
Manufactured in
1100 Campus Rd, Princeton, NJ, United States
Products
CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1395-2022Don't want to check this manually?
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