FDAJune 22, 2022device
CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor.
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
integra lifesciencesintegra
UPCs
10381780533778
Recall history
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