Recall Z-1023-2013 ยท DQK Computer, Diagnostic, Programmable
Biosense Webster, Inc.
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.
| Date | Mar 28, 2013 (initiated Mar 5, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 54 units |
| Distribution | Worldwide Distribution - USA (Nationwide) including the states of: DE, NL, CH, FR, GB, DK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120550 | CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD) Biosense Webster, Inc., May 7, 2012 |