CDI 500 Blood Parameter Monitoring System — Class II medical device recall Z-2742-2015
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2015-09-16, distributed nationwide. Inaccuracies in SvO2, temperature, pH, pCO2, pO2, Hematocrit, and Potassium readings following a software upgr
| Recall number | Z-2742-2015 |
|---|---|
| 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 | 2015-08-07 |
| Classified | 2015-09-08 |
| Reported by FDA | 2015-09-16 |
| Terminated | 2016-05-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, CA, CL, CO, HK, ID, JP, KR, MX, MY, PH, SG, TH, TW |
| Quantity | 4,638 |
| Reason classes | software |
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 for recall
Inaccuracies in SvO2, temperature, pH, pCO2, pO2, Hematocrit, and Potassium readings following a software upgrade to version 1.69.
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-2742-2015. 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.