FDA Device recall Z-1731-2013
CDI Blood Parameter Monitoring System 500 with Arterial 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 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-1731-2013 |
| 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 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: 500AHCT* and serial numbers: 1023,1025-1027,1029-1031, 1034,1035,1037,1040, 1045, 1048, 1054-1058, 1060…Catalog number: 500AHCT* and serial numbers: 1023,1025-1027,1029-1031, 1034,1035,1037,1040, 1045, 1048, 1054-1058, 1060-1062, 1064, 1065, 1072-1074, 1076-1095,1098-1100,1106-1110,1114,1116-1129,1131,1132,1141-1145, 1153-1165,1169-1180,1186-1191,1194-1210, 1212-1215,1221, 1230, 1237-1243,1249-1253,1256-1260,1265-1269,1275-1284,1290-1294,1300-1303, 1310, 1311, 1316-1320, 1322-1331,1335-1339,1345-1349,1359, 1378,1384-1388, 1394-1398,1409-1413,1419,1434-1438,1444-1448, 1454-1458, 1469-1478, 1481, 1482, 1484-1493,1495-1503,1505-1520,1528,1531-1553, 1555-1558,1567-1596,1607-1616,1632-1636,1647-1656,1667-1671,1677-1681,1687-1696, 1702-1711,1717-1721,1728-1732,1738-1753, 1759-1775,1777-1786,1790-1794,1796-1804,1810-1814,1820-1829,1831-1843,1847-1850, 1856, 1861-1885, 1891-1900, 1906-1915,1921-1925,1931-1935,1941-1950,1975,1986-2015, 2017-2022, 2024-2028, 2039, 2041-2044, 2046-2058, 2064, 2068, 2069, 2078-2085, 2087-2096, 2108, 2116, 2118- 2122, 2132-2137, 2143-2148, 2156-2176, 2183, 2184, 21 |
|---|
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-1731-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.