Z-2742-2015Class II

CDI 500 Blood Parameter Monitoring System. Provides continuous, on-line monitoring of the extracorporeal...

Name: Z-2742-2015 CDI 500 Blood Parameter Monitoring System. Provides continuous, on-line monitoring of the extracorporeal...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2015-08-07
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2015-08-07 / Terminated / root cause: software

FDA source

Terumo Cardiovascular Systems Corporation began a recall of CDI 500 Blood Parameter Monitoring System. Provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and and carbon dioxide, pH... on 2015-08-07. FDA classified it as Class II and gives the reason as "Inaccuracies in SvO2, temperature, pH, pCO2, pO2, Hematocrit, and Potassium readings following a software upgrade to version 1.69". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2742-2015
Classification: Class II
Status: Terminated
Initiated: 2015-08-07
Posted: 2015-09-09
Terminated: 2016-05-31
Recalling firm: Terumo Cardiovascular Systems Corporation
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.
Product code: DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Reason for recall: Inaccuracies in SvO2, temperature, pH, pCO2, pO2, Hematocrit, and Potassium readings following a software upgrade to version 1.69.
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 4638
Distribution: 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.
Product codes and lots: 500A, 500AHCT, 500AV, 500AVHCT CDI Blood Parameter Monitoring System 500; software version 1.69.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2742-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2742-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-16	2015-09-08

Product code DRY

K133658Class IICdi Blood Parameter Monitoring System 500Terumo Cardiovascular Systems Corp. / cleared 2014-07-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)