January 9, 2014
Company:Covodien. Date of Enforcement Report:1/9/2014 Class l: PRODUCT Puritan Bennett 840 ventilator systems software part number 4-070212-85, revision AB-AG._x000D_ _x000D_ The intended use of the product is to provide mechanical ventilation to patients. Recall Number Z-0611-2014 REASON Due to a software problem, a diagnostic code (XB0069) may be triggered. This causes the ventilator to stop...
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Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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