FDA
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Air bubbles trapped in the PO2 electrode will cause falsely elevated patient test results.
An urgent device correction letter dated 12/16/02 was sent to each customer. The letter advised of the problem and instructed customers to follow a strict quality control regime to ensure proper electrode performance. Customers were instructed how to automatically lock the affected parameter so that patient results will not be reported if QC performance violates the customer''s programmed rules.