Company: Terumo Cardiovascular Systems Corporation
Date of Enforcement Report 9/16/2015
Class lI:
PRODUCT
CDI 500 Blood Parameter Monitoring System. Provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature.
Recall Number Z-2742-2015
REASON
Inaccuracies in SvO2, temperature, pH, pCO2, pO2, Hematocrit, and Potassium readings following a software upgrade to version 1.69.
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corporation, Ann Arbor, MI on 8/7/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
4638
DISTRIBUTION
Nationwide and Internationally.
___________________________________
