20-Pole Eco Cable, Catalog #EM-5050-060 Product Usage: The 20-Pole Eco Cable is intended to be used as an interface cabl
FDA device recall Z-1023-2013 · posted 2013-03-28 · Terminated
Recall details
- Recalling firm
- Biosense Webster, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- DQK
- Quantity affected
- 54 units
- Distribution
- Worldwide Distribution - USA (Nationwide) including the states of: DE, NL, CH, FR, GB, DK.
- Date initiated
- 2013-03-05
- Date posted
- 2013-03-28
- Date terminated
- 2013-10-17
- Location
- Irwindale, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD) (K120550) | Biosense Webster, Inc. | 2012-05-07 |