Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System — Class II medical device recall Z-0802-2013
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2013-02-20. Inaccurate readings. Software contains unused (turned off) accuracy correction factors for slope (gain) and of
| Recall number | Z-0802-2013 |
|---|---|
| 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 | 2010-11-01 |
| Classified | 2013-02-12 |
| Reported by FDA | 2013-02-20 |
| Terminated | 2013-11-08 |
| Quantity | 622 units |
| Reason classes | software |
| Serial numbers | 0503, 1000, 1017, 1070, 1071, 1073, 1074, 1076, 1077, 1080, 1082, 1083, 1107-1110, 1115-1117, 1124, 1126-1134, 1136, 1137, 1139-1146, 1148-1152, 1154-1156, 1159-1162, 1164-1166, 1168-1177, 1182 and 60 more |
| Model numbers | 101 |
Product
Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors blood/oxygen saturation, hematocrit and hemoglobin levels.
Reason for recall
Inaccurate readings. Software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations. The accuracy on any cuvette size did not meet the specifications.
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.