CDI Blood Parameter Monitoring System 500 with Venous blood parameter… — Class II medical device recall Z-1734-2013
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2013-07-24, distributed nationwide. Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains ina
| Recall number | Z-1734-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo Cardiovascular Systems Corporation, Ann Arbor, MI, United States |
| Recall initiated | 2013-02-27 |
| Classified | 2013-07-13 |
| Reported by FDA | 2013-07-24 |
| Terminated | 2016-02-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, CA, HK, JO, JP, KR, MX, MY, PH, SG, TH, TW |
| Reason classes | software |
| Serial numbers | 1564-1566 |
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.
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1734-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.