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U.S. Department of Health and Human Services

Class 2 Device Recall CDI 101 Hematocrit/Oxygen Saturation Monitoring System

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  Class 2 Device Recall CDI 101 Hematocrit/Oxygen Saturation Monitoring System see related information
Date Initiated by Firm November 01, 2010
Date Posted February 12, 2013
Recall Status1 Terminated 3 on November 08, 2013
Recall Number Z-0802-2013
Recall Event ID 60695
Product Classification Monitor, blood-gas, on-line, cardiopulmonary bypass - Product Code DRY
Product Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors blood/oxygen saturation, hematocrit and hemoglobin levels.
Code Information Catalog number: 101 and 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, 1185-1190, 1192,1193, 1195, 1197, 1198, 1225, 1228, 1229, 1237, 1239-1241,1243-1245,1247, 1249-1326, 1332-1339, 1344-1347, 1349, 1350-1363, 1365-1409, 1411-1436,1438, 1440-1447, 1449-1453, 1455-1463,1465-1482,1484-1492,1494-1552,1555-1565, 1567-1600,1602,1605-1607,1609-1611,1613-1623,1625-1629,1632-1651,1653, 1655-1660, 1662-1664, 1666, 1667,1669-1679,1681-1684,1686,1689-1691, 1693-1710,1712-1715,1717-1750,1752-1757,1759-1771,1773-1785,1787,1788,1790-1809, 1811-1831,1833,1838,1839,1855-1858,1866, and TK001-TK011.
Recalling Firm/
Manufacturer
Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor MI 48103-9586
For Additional Information Contact
734-741-6173
Manufacturer 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.
FDA Determined
Cause 2
Software design
Action Terumo sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated November 1, 2010 to all affected customers. The letter identified the product, problem, and the actions to be taken by the customers. Contact Terumo CVS Customer Service at 1-800-521-2818 for questions or concerns.
Quantity in Commerce 622 units
Distribution Worldwide Distribution.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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