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.
FDA Recall Z-2742-2015 · Posted 2015-09-09
Advertisement
Recalling FirmTerumo Cardiovascular Systems Corporation
Recall StatusTerminated
Product CodeDRY
Date Initiated2015-08-07
Date Terminated2016-05-31
Product Quantity4638
Reason for Recall
Inaccuracies in SvO2, temperature, pH, pCO2, pO2, Hematocrit, and Potassium readings following a software upgrade to version 1.69.
Firm Action
A voluntary Urgent Medical Device Correction notice that clearly explains initial in-vivo calibration requirements, device operating ranges, and temperature measurements was sent on 08/17/2015, via express mail to consignees of CDI System 500 v1.69. Following the initial notice, Terumo will be updating the Operators Manual and will send the new manual to each consignee when available. One manual per unit at each facility will be provided. Customers with questions and return response forms may contact:
Terumo Recall Email: [email protected]
Terumo Recall Fax: 734-741-6149
Terumo CVS Customer Service: 1.800.521.2818, Monday - Friday, 8 a.m. 6 p.m. ET.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution-US (nationwide) including DC and PR and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and the countries of Australia, Belgium, Canada, Chile, Colombia, Hong Kong, Indonesia, Japan, Malaysia, Mexico, Philippines, Singapore, South Korea, Taiwan, Thailand, United Arab Emirates.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement