FDA Device recall Z-1730-2013
CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe
- FDA Device
- Class II
- terminated
- Published 2013-07-24
On 2013-07-24 the FDA classified a Class II recall of CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe by Terumo Cardiovascular Systems, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1730-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-02-27 |
| Published | 2013-07-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Terumo Cardiovascular Systems |
| Distribution | US |
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
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
Identifiers
| code_info | Catalog number: 500AVHCT* and serial numbers: 0012, 1001-1022, 1024, 1028, 1032, 1033,1036, 1038, 1039, 1041-1044, 1046…Catalog number: 500AVHCT* and 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, 1111-1304-1309,1312-1315,1321,1332-1334,13401344,1350-1354, 1357, 1358, 1379-1383, 13891393,1399-1408,1414-1418, 1421, 1422, 14241433, 1439-1443, 1449-1453, 1459-1463, 1466,1479, 1480, 1494, 1525, 1554, 1597-1601,1605,1617-1631,1637-1646,1657-1661,16721676,1682-1686,1697-1701,1712-1716, 1733-1737, 1787-1789, 1805-1809, 1815-1819, 1830, 1844-1846, 1857-1860, 1886-1890, 1901-1905,1916-1920, 1926-1930, 1936-1940, 1953-1974,1976-1985, 2029-2034, 2036-2038, 2040, 2045, 2059-2063, 2065-2067, 2070-2077, 2086, 2097-2101, 2109-2111, 2113-2115, 2123-2131, 2138-2142, 2149-2155, 2177-2182, 2185-2187, 2189,2195-2199, 2214, 2216-2219, 2224, 2228-2231, 2243-2245, 2249-2253, 2255-2258, 2260, 2263, 2265-2268, 2275-2277, 2279, 2285-2291, 22952298, 2313-2321, 2323-2329, 2338-2354, 2357, 2366,2368-2375,2377,2392,2403-2408,241 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1730-2013%22
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