CDI Blood Parameter Monitoring System 500 with Arterial and Venous… — Class II medical device recall Z-1730-2013
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-1730-2013 |
|---|---|
| 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 | 0012, 1001-1022, 1024, 1028, 1032, 1033, 1036, 1038, 1039, 1041-1044, 1046, 1047, 1049-1053, 1059, 1063, 1066-1071, 1075, 1096, 1097, 1101-1105, 1111-1304-1309, 1115, 1130, 1133-1140, 1146-1152 and 292 more |
Product
CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe. 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
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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.