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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 Device Recall 20Pole Eco Cable see related information
Date Initiated by Firm March 05, 2013
Date Posted March 28, 2013
Recall Status1 Terminated 3 on October 17, 2013
Recall Number Z-1023-2013
Recall Event ID 64579
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 CA 91706-2006
For Additional Information Contact
909-839-8500
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		 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 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.
510(K) Database 510(K)s with Product Code = DQK and Original Applicant = BIOSENSE WEBSTER, INC.
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