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U.S. Department of Health and Human Services

Class 2 Device Recall 20Pole Eco Cable

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 Class 2 Recall
20Pole Eco Cable
see related information
Date Posted March 28, 2013
Recall Status1 Terminated on October 17, 2013
Recall Number Z-1023-2013
Recall Event ID 64579
Premarket Notification
510(K) Number
K120550 
Product Classification Computer, Diagnostic, Programmable - Product Code DQK
Product 20-Pole Eco Cable, Catalog #EM-5050-060 Product Usage: The 20-Pole Eco Cable is intended to be used as an interface cable between the LASSO NAV Eco Catheter and CARTO 3 System.
Code Information Impacted serial Numbers: 120, 132, 134,136, 151, 342, 350, 354, 356, 363, 368, 373, 379, 380, 384, 385, 402, 405, 424, 919, 953, 954, 960, 963, 968, 970, 977, 980, 993, 998, 1001, 1123, 1148, 1378, 1596, 1729, 1745, 1747, 1749, 1750, 1751, 1753, 1754, 1758, 1759, 1760, 1761, 1797, 1799, 1802, 1803, 1804, 1805. Lot Numbers: P1210, P1220, P1221, P1231.
Recalling Firm/
Manufacturer
Biosense Webster, Inc.
15715 Arrow Hwy
Irwindale, California 91706-2006
Manufacturer Reason
for Recall
Biosense is recalling the 20-Pole Eco Cable because it was incorrectly calibrated. When a catheter is connected to an affected to an affected 20-Pole Eco Cable, the catheter will not be recognized by the impacted 54 cable serial numbers within the field.
FDA Determined
Cause 2
TRAINING: Employee Error
Action Biosense Webster sent an Urgent Field Notice Medical Device Letter dated March 5, 2013 to all affected customers. The letter identified the affected product, problem and the actions to be taken. Customers with questions are instructed to contact Biosense Webster sales representatives or call (866) 473-7823, Mon-Friday from 7amto 8pm EST.
Quantity in Commerce 54 units
Distribution Worldwide Distribution - USA (Nationwide) including the states of: DE, NL, CH, FR, GB, DK.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DQK and Original Applicant = BIOSENSE WEBSTER, INC.
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