Z-1734-2013Class II

CDI Blood Parameter Monitoring System 500 with Venous blood parameter module. Intended for use during...

Name: Z-1734-2013 CDI Blood Parameter Monitoring System 500 with Venous blood parameter module. Intended for use during...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2013-02-27
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2013-02-27 / Terminated / root cause: software

FDA source

Terumo Cardiovascular Systems Corporation began a recall of CDI Blood Parameter Monitoring System 500 with Venous blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous... on 2013-02-27. FDA classified it as Class II and gives the reason as "Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains inaccuracies associated with a software algorithm, and a software update has been developed to address this...". 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-1734-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-27
Posted: 2013-07-13
Terminated: 2016-02-17
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: CDI Blood Parameter Monitoring System 500 with Venous blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.
Product code: DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Reason for recall: Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains inaccuracies associated with a software algorithm, and a software update has been developed to address this issue and a premarket notification (K130425) has been submitted to the agency. Once clearance is received for this premarket notification from the US FDA, Terumo CVS will implement the
Root cause tag: software
FDA root cause: Software design
Action: On 2/27/13, all consignees will receive a recall notification letter via Federal Express. Terumo CVS will correct all affected CDl Monitors. Correction to the devices will be completed concurrently with BPM replacements related to Z-2185/2189-11 RES 57194. Terumo continues to manufacture and ship devices affected by this recall. The long term corrective actions are associated with Recall# Z-2185/2189-11 RES 57194. As committed previously, we will re-notify all customers once we are ready to implement the fix for the BPM in the field. All units produced prior to the change in manufacturing will be included in the scope of this correction. Terumo continues to manufacturer units affected by this correction. All units returned for this correction will be tagged with a service traveler to indicate reason for correction and units will be properly segregated to prevent unintended re-shipment.
Quantity in commerce: 3972 units since 4/26/12
Distribution: Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, 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, and WV and the countries of Jordan, CANADA, AUSTRALIA, Japan ,Hong Kong ,UNITED ARAB EMIRATES (UAE), BELGIUM, South Korea, Malaysia, Mexico, Philippines, Singapore, Taiwan, and Thailand.
Product codes and lots: Catalog number: 500V* and serial numbers: 1564-1566

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1734-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1730-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-24	2013-07-13
Z-1731-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-24	2013-07-13
Z-1732-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-24	2013-07-13
Z-1733-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-24	2013-07-13
Z-1734-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-24	2013-07-13

Product code DRY

K972962Class II3M Cdi Blood Parameter Monitoring System 5003M Company / cleared 1997-11-06

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)