Recall Z-2742-2015— Terumo Cardiovascular Systems Corporation

Name: FDA recall Z-2742-2015
Creator: U.S. Food and Drug Administration
Published: 2015-08-07

Class II · Terminated

Class II FDA medical device recall by Terumo Cardiovascular Systems Corporation, initiated 2015-08-07, terminated 2016-05-31. It names one FDA 510(k) clearance: K133658. 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.. Reason: Inaccuracies in SvO2, temperature, pH, pCO2, pO2, Hematocrit, and Potassium readings following a software upgrade to version 1.69..

Recalling firm: Terumo Cardiovascular Systems Corporation
Classification: Class II
Status: Terminated
Initiated: 2015-08-07
Terminated: 2016-05-31
Firm location: Ann Arbor, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K133658 — CDI BLOOD PARAMETER MONITORING SYSTEM 500Terumo Cardiovascular Systems Corp.·cleared 2014-07-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Inaccuracies in SvO2, temperature, pH, pCO2, pO2, Hematocrit, and Potassium readings following a software upgrade to version 1.69.

Data sourced from openFDA. This site is unofficial and independent of the FDA.